DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA.  NDC 0409-2344-02
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
XOCHITL(so cheel)  Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351  DALLAS, TEXAS 75252
Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm.
XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; Mild; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351  DALLAS, TEXAS 75252
Chile Con Queso; AN ALL NATURAL SPICY CHEESE DIP;Net Weight 16 oz. (454g); DISTRIBUTED BY STONEWALL KITCHEN; STONEWALL LANE,  YORK MAINE 03909 USA  800-207-JAMS;  STONEWALLKITCHEN.COM
US Distribution including the states of PA, MD, UT, TX, OH, GA, MO, FL, CO, and WA.
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
All brochures and online literature printed before November 20, 2013.
3,346 brochures.  Quantity not applicable to web site.
Brochures and web site information for the Hyper blue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA.  Specifically, the web site and brochures misbranded the product with claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, as well as a claim that the product could be used with a 15 mm hand piece.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.
0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015
Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL)  Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light,  62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Worldwide Distribution - Nationwide (USA and Puerto Rico), and foreign:  Latin America, Asia Pacific, Canada, Europe, Africa and Middle East, and Japan.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
Units may be labeled with the incorrect diopter power.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0, 13.5, 14.0   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5, 15.0   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 15.5, 16.0   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 17.5, 18.0   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 18.5-19.0   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24.   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5, 25, 25.5 & 26.   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5, 27, 27.5 & 28.5.   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29, 29.5 & 30.   Product Usage:  AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.
Worldwide Distribution - USA (nationwide) including the country of Canada.
Gel-E Donut, Squishon 2 gel pillows   Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold.  The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
Blood product, collected from a donor who reported travel to an area possibly endemic for malaria, was distributed.
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Shadow Valley Farm product distributed to retail stores in CT and MA.  Fish Family Farm Brand Products were only sold at the firm's retail store.
FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOMOGENIZED in a glass half-gallon container
Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio).
FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A 2% Reduced Fat Milk Pasteurized and Homogenized in a glass half-gallon container
FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A FAT FREE SKIM MILK Pasteurized and Homogenized in a glass half-gallon container
FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A WHOLE MILK Pasteurized and Homogenized in a glass half-gallon container
FISH FAMILY FARM INC. GRADE A PASTEURIZED HEAVY CREAM in glass pints, quarts, half-gallons
Doctor's Best  Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673
Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug.
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only.  Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
The product was distributed domestically and to internationally. Domestically to CA, PA, IA, CO, NY, MD, NC,AL, AZ, IL, GA, VA. Netherlands, Argentina,
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone  Device Common Name: Drill Guide DNP 3.3mm  Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
Catalog Number:  DNPDG, Lot Number:  NB0311 and NB0611
The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.
Worldwide Distribution - USA including  AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX & VA and Internationally to AUSTRALIA, FRANCE, INDIA, ITALY, and GERMANY.
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile   The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel.
The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.
Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length.   Product Usage:  The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.
Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lots.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
Double Offset Rasp Handle, Left Hand Nonsterile
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Item Number 82016757830          Lot Number 97009559
Double Offset Rasp Handle, Right Hand Nonsterile
Item Number 82016757931                          Lot Number 97009560
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.
Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.
Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ  08872, NDC 13811-558-30, UPC 3 13811 55830 2.
Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who disclosed history that warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood product, which was also tested as part of a clinical trial, but was not handled according to protocol, was distributed.
Blood product, collected from a donor who emigrated from a malarial endemic country, was distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Blood products,that did not undergo quality control testing for pH or platelet count, were distributed.
Worldwide Distribution - USA Nationwide and the countries of Scotland, Ireland, United Kingdom, Canada, Australia, and New Zealand.
IntelePACS software versions 3-8-1 to 4-9-1,    Product Usage:  IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
In specific situation a partially truncated file may be written to the IntelePACS server.  This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete.  This situation only occurs if a file is partially truncated.
Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of components. The components are the following: 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.
ANX 3.0 unit numbers:  193 through 1203.
Ansar Group, Inc. recalled the blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system because of complaints that it occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
PENTAX Upper/Lower G.I. Endoscope  OF-B130 and OF-B194 Gas/Water Feeding Valve
The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
CA, KY, LA, MN, MS, NC, NJ, NY, OH, OK, PA, TX, VA
Jody's, Funfetti, Net Wt 7.5 oz (213 g) and  4 oz in clear cellophane bag.
Undeclared colors Blue #1, Red #3 and Yellow #5.
Jody's, Freedom Funfetti; Net Wt 7.5 oz (213 g)  in clear cellophane bag.
Undeclared colors Blue #1, Blue #2 and Red #40.
Jody's, Breast Cancer Awareness Kettle Corn; Net Wt 3oz  in clear cellophane bag.
Worldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017.    Product Usage:  Used to conduct syncope examinations.
Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal.  The product was manufactured with a component that can cause the device to malfunction.
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019.      Product Usage:  Used to conduct syncope examinations.
Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217.     Product Usage:  Used to conduct syncope examinations.
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219.      Product Usage:  Used to conduct syncope examinations.
Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, ,MN, MS, NH, HY, OH,OR, PA, TN TX, UT, VA, WA, WI,and  WV. and the country of CANADA.
Gyrus ACMI Falope-Ring Dilator, item 000878-4.  The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30).  The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube.  The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits.  Each kit is provided sterile and includes one dilator and two Falope Bands.
catalog No.:  000878-4, not lot controlled.
Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component.  The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016
Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015
Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit  per carton box, Product Number 800480, Batch
Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016
X-MARS Set (component of MARS Treatment Kit Type 1116/1  X-MARS US), Product Number 800541
Model Number MARS Treatment Kit Type 1116/1  X-MARS US, Batch Number 0000020229, Expiry Date 02/2017
Worldwide Distribution - US Nationwide and the countries of  AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL
TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 34 CM NAIL, 130o, LEFT, REF 71676575, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116    TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 34 CM NAIL, 130o, RIGHT, REF 71676576, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116    TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 36 CM NAIL, 130o, LEFT, REF 71676577, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116    TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 36 CM NAIL, 130o, RIGHT, REF 71676578, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116    TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 38 CM NAIL, 130o, LEFT, REF 71676579, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116    TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 38 CM NAIL, 130o, RIGHT, REF 71676580, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 40 CM NAIL, 130o, LEFT, REF 71676581, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 40 CM NAIL, 130o, RIGHT, REF 71676582, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 42 CM NAIL, 130o, LEFT, REF 71676583, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 42 CM NAIL, 130o, RIGHT, REF 71676584, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 44 CM NAIL, 130o, LEFT, REF 71676585, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 125o, LEFT, REF 71676597, QTY (1), STERILE R,  TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 125o, RIGHT, REF 71676598, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 38 CM NAIL, 125o, RIGHT, REF 71676602, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 40 CM NAIL, 125o, LEFT, REF 71676603, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 42 CM NAIL, 125o, RIGHT, REF 71676606, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 44 CM NAIL, 125o, RIGHT, REF 71676608, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 32 CM NAIL, 130o, RIGHT, REF 71676618, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 130o, RIGHT, REF 71676620, QTY (1), STERILE R,   TRIGEN(R) INTERTAN(TM)
There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Nellcor Puritan Bennett Inc. (dba Covidien LP)
US distribution to states of:  LA, IL, MS, CO, IN, GA, CA and TX.
Vital Sync'' VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device.  CDs are packaged in clam shell jeweled cases within a carton box.   The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and  TX.
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003.   The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture,  and release particulate during use.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of  AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
Persona (TM) The Personalized  Knee System PS Tibial Articular Surface Provisional Top  Nonsterile    TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 3-5 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 6-9 CD TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 3-5 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 6-9 EF TOP  TASP PS L 10-11 EF TOP  TASP PS L 10-11 EF TOP  TASP PS L 10-11 EF TOP  TASP PS L 10-11 EF TOP
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs).  This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
Persona (TM) The Personalized  Knee System Tibial Articular Surface Provisional Bottom  Nonsterile    TASP L CD BOTTOM, +0MM  TASP L CD BOTTOM, +6MM  TASP L EF BOTTOM, +0MM  TASP L EF BOTTOM, +6MM  TASP L GH BOTTOM, +0MM  TASP L GH BOTTOM, +6MM  TASP L J BOTTOM, +0MM  TASP L J BOTTOM, +6MM  TASP R CD BOTTOM, +0MM  TASP R CD BOTTOM, +6MM  TASP R EF BOTTOM, +0MM  TASP R EF BOTTOM, +6MM  TASP R GH BOTTOM, +0MM  TASP R GH BOTTOM, +6MM  TASP R J BOTTOM, +0MM  TASP R J BOTTOM, +6MM
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
Persona (TM) The Personalized  Knee System CR Tibial Articular Surface Provisional Top  Nonsterile    TASP CR L 3-9 CD TOP
Persona (TM) The Personalized  Knee System UC Tibial Articular Surface Provisional Top  Nonsterile  TASP UC L 3-7 CD TOP  TASP UC L 4-11 EF TOP  TASP UC L 7-12 GH TOP  TASP UC L 9-12 J TOP
Persona (TM) The Personalized  Knee System Tibial Articular Surface Provisional Bottom  Nonsterile  PSN A/S PROV L CD BOTTOM +0MM  PSN A/S PROV L CD BOTTOM +6MM  PSN A/S PROV L EF BOTTOM +0MM  PSN A/S PROV L EF BOTTOM +6MM  PSN A/S PROV L GH BOTTOM +0MM  PSN A/S PROV L GH BOTTOM +6MM  PSN A/S PROV L J BOTTOM +0MM  PSN A/S PROV L J BOTTOM +6MM  PSN A/S PROV R CD BOTTOM +0MM  PSN A/S PROV R CD BOTTOM +6MM  PSN A/S PROV R EF BOTTOM +0MM  PSN A/S PROV R EF BOTTOM +6MM  PSN A/S PROV R GH BOTTOM +0MM  PSN A/S PROV R GH BOTTOM +6MM  PSN A/S PROV R J BOTTOM +0MM  PSN A/S PROV R J BOTTOM +6MM
Persona (TM) The Personalized  Knee System CPS Tibial Articular Surface Provisional Top  Nonsterile  TASP MLC L 3-5 CD TOP  TASP MLC L 6-9 CD TOP  TASP MLC L 3-5 EF TOP  TASP MLC L 6-9 EF TOP  TASP MLC L 10-11 EF TOP  TASP MLC L 6-9 GH TOP
National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded  Sterile  zimmer, WARSAW, IN 46580, U.S.A.
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw  Sterile  zimmer, WARSAW, IN 46580, U.S.A.
6.5 mm Cancellous Screw Fully Threaded Sterile  zimmer, WARSAW, IN 46580, U.S.A.
6.5 mm Cancellous Screw 16 mm Thread Length Sterile  zimmer, WARSAW, IN 46580, U.S.A.
6.5 mm Cancellous Screw 32 mm Thread Length Sterile  zimmer, WARSAW, IN 46580, U.S.A.
6.5 mm Cancellous Screw Fully Threaded  Sterile  zimmer, WARSAW, IN 46580, U.S.A.
4.5 mm Malleolar Screw Sterile  zimmer, WARSAW, IN 46580, U.S.A.
4.0 mm Cancellous Screw, Partially Threaded Sterile  zimmer, WARSAW, IN 46580, U.S.A.
Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.
Navigation Spine & Trauma 3D Version 2.0 and  2.1   Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data.    The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
Brainlab Navigation Software Spine &amp; Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner.    The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available, the so-called &quot;table-zero-position&quot; is sent from the CT scanner to the Brainlab navigation software in a special format.     Due to a change in the corresponding Siemens data output, the information from the CT scanner cannot be correctly processed in the navigation software, when using:     1) Automatic Registration of iCT Data, in combination with   2) Siemens SOMATOM Definition AS CT scanner with Software Somaris SOM 7 (or higher), and   3) Automatic Gantry Communication (available for Spine &amp; Trauma 3D 2.0 and 2.1 only).     As a result, in the navigation software the CT image data set appears shifted in the scanner movement direction (patient head-feet direction). The scale of the shift can differ in each scan, varying from sub-millimeters to meters.
USA (nationwide) Distribution and Internationally to Canada.
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension&reg; Chemistry Wash lot RD41041.   Internal investigation has confirmed bacterial contamination in ChemistryWash lot RD41041. A positive bias will be observed on CTNI, LTNI, TSH, PBNP and LPBN and a negative bias will be seen on FT4 when this lot is first placed on the instrument without recalibration of methods. Recalibration of these assays when using this lot will not correct the problem and may cause falsely high or low results.
Blood product, collected from a donor considered to be at risk for variant Creutzfeldt- Jakob Disease (vCJD), was distributed.
Ciranda Organic Carob Powder Light, Product Code 20030.  Net Wt.  55.11 lbs / 25 kg.  Ingredients:  Organic Carob Powder.  Manufactured in Italy.
Ciranda is recalling one lot of Organic Carob Powder Light after learning that a customer received a positive test for Salmonella.
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood products, collected from an ineligible donor, were distributed.
Red Blood Cells Frozen Leukocytes Reduced
Blood product for which some quality control procedures were not performed, was distributed.
Nationwide in US and worldwide to: Canada, UK, Russia, Korea, Hong Kong, Libya, Iran, Iraq, Kuwait, Singapore, Armenia, Egypt, Pakistan, Sweden, New Zealand, Poland, Germany, Italy, UAE.
WaterLase iPlus Dental Laser System, Part No. 7200854-XX   Software Upgrade Kit, Part No. 6201463.
Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7).  If an error occurs in the procedure screen, the air setting will change to 1% and OFF.
AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI AND WV.
American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid   e. Total package size (e.g. 12 packages per case):  12 jars per case
Organic Carob Powder, Net Wt. 55lbs (25kg), Product Code: CAROB-100
BrandStorm is recalling Organic Carob Powder because it may be contaminated with Salmonella.
D.A. Stein Culinary Group, LLC dba Brett Anthony Foods
Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. per jar. This product is labeled to keep refrigerated.
Batch Numbers and Expiration Dates:  1) Batch 14196, Expires 7/26/14;   2) Batch 14198, Expires 7/28/14;   3) Batch 14200, Expires 7/30/14;   4) Batch 14203, Expires 8/2/14
Brett Anthony Foods is recalling Sesame Ginger Dressing because the allergen almonds (a tree nut) is not listed in the ''Contains'' allergen warning statement although almonds are listed in the list of ingredients.
Worldwide Distribution - US Nationwide and the country of  Japan.  No military/govt/VA consignees.
Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY   Product Usage:  Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
Patella 38mm, REF164-0038    Product Usage:  UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
PS Tibial Insert, REF 163-1XXX   Product Usage:  UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
PS Tibial Insert Size 3  8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3  9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3  12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4  7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4  7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5  9mm,Part 163-1509,Lot A135827,
Tibila Insert UC, Balanced Knee System, REF163-3YYY   Product Usage:  UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746,
Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY   Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666
Alabama, Connecticut, Maryland, Massachusetts, Rhode Island, South Carolina, District of Columbia, Mississippi, Tennessee, Florida, New Hampshire, Texas, Georgia, New York, Virginia, Illinois, Louisiana, North Carolina, Puerto Rico
Product is in a 160 gram, light green tin container, labeled in part: ''ecoato Sweet Paprika Powder Product of Spain''
GA, NH, CT, IA, PA, WA, IN, TX OH, AZ, FL, MD
Rising Moon Organics Butternut Squash Ravioli,  Organic, Vegetarian & Delicious;        Keep Frozen;  Net Wt. 8 oz.  UPC: 7-85030-55557-6.    Manufactured for Rising Moon Organics.  Manufactured by: Carmel Food Group,  Hayward, CA
Sell by APR 09 2015; Product code 55557.
Consumer complaint alerted firm that one date code of Butternut Squash Ravioli, may actually contain Spinach Florentine Ravioli that contains milk, egg and soy ingredients that are not listed as ingredients of the package.
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
CaCoCo Superfood Drinking Chocolate; Global Warrior - Flavor Melody: Dark, Bitter-sweet, Medicinal, Energizing Raw Chocolate.  Gluten-free/Vegan/Raw    Sold in 8 .14 oz (231 g). o and 2 lb. bags.  Ingredients: Cacao Beans, Cacao Butter, Maca, Carob, coconut Crystal Sugar, Mesquite, Wildcrafted Shilajit, Vanilla Bean, Turmeric, Cardamon, Orange Peel, Himalayan Salt, Whole Leaf Stevia.    Manufactured at 13425 Snow Mt. Camp Road, Nevada, CA    UPC 091131352076
Firm used organic powder that is now under recall by supplier for potential contamination with Salmonella.
CaCoCo Superfood Drinking Chocolate; Original - Flavor Melody: Sweet, Playful, Perfectly Spiced Raw  Chocolate.  Gluten-free/Vegan/Raw    Sold in 8 .14 oz (231 g). o and 2 lb. bags.  Ingredients: Cacao Butter, Maca, Coconut Crystal Sugar,Carob, Cacao Bean, Cacao Powder, Lucuma, Himalayan Salt, Vanilla Bean, Cinnamon, Nutmeg, Cayenne.     Manufactured at 13425 Snow Mt. Camp Road, Nevada, CA    UPC 09113152113
California, Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana,  Arizona, Indiana, South Dakota, Missouri & Montana. In addition to   Korea, B.V., Japan, Puerto Rico, & Canada
Vanguard 360 Femoral Boss Reamer,  Label: REF 32-488474  VANGUARD 360 1NSTRUMENT  FEMORAL BOSS REAMER  NON-STERILE,   BIOMET ORTHOPEDICS  56 EAST BELL DRIVE  P.O. BOX 587 WARSAW, IN 46581 USA
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
Distributed in the states of: MA, NC, OH, and TX.
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only.    The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228  (303) 986-4600
Natural Grocers by Vitamin Cottage is recalling Chunks of Energy Carob Greens and Chunks of Energy Date Flax/Tumeric due to the potential presence of Salmonella.
Natural Grocers Organic Chunks of Energy Date Flax Turmeric, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228  (303) 986-4600
Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03)  Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of US:; AL, AK, AZ, CA, CO, CT, FL, GA, HI, IL IN, IA, KS,KY, LA, MD, MA, MI, MO, MT, NE, NV, NJ, NM, NY, NC,ND, OH,OK, OR, PA, SC, SD, TX, UT, VA, WV, and WI, and the countries of AUSTRALIA, BELGIUM CANDA, CHINA, EL SALVADOR, ENGLAND, FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NETHERLANDS, PHILIPPINE, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2).  .
Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2).  Accuray has identified potential safety issues (anomalies) with these software versions.
Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd  a TERUMO company
The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Philips IP5 Information Portal   The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of  AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and  SWITZERLAND.
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1).    The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.
Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.
ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL  60015 USA, Product Code 2B6186, NDC 0338-0499-06.
Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
USA:  AL, CA, CO, FL, GA, HI, IL, IN, KS, LA, MD,MI, MN, MO, MT, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI.   OUS:  ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, CANADA, CHILE CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, RUSSIA, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN,THAILAND, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.
GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad'' detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported.
Nationwide Distribution - USA including AL and MD.
CAP Change Kit w/MicroClave Clear, Item No. B78109   BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Cap Change Kit with MicroClave Clear Connector, Item No. B79103   BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Port Access Kit with MicroClave Clear Connector, Item No. B79104   BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
US and  Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
A problem was detected in the Philips IntelliSpace PAC 4.4 software where  if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
Worldwide Distribution - US including the states of  CA, GA, NC, NH, NY and OR., and the countries of Canada and Spain.
Philips IntelliSpace ECG Management System,  with software option C61 needed to import ECGs from the Quinton Stress ECG System.   Model No. 860426
Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.
Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe,  COMPOUNDED DRUG   For Institutional or Office Use Only--Not for Resale   Federal Law Prohibits Dispensing without Prescription  Healix Infusion Therapy, Inc.  (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478   NDC 75901-8008-90
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it  because fliptop vial crimps were loose or missing.
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG   For Institutional or Office Use Only--Not for Resale   Federal Law Prohibits Dispensing without Prescription  Healix Infusion Therapy, Inc.  (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag,  COMPOUNDED DRUG   For Institutional or Office Use Only--Not for Resale   Federal Law Prohibits Dispensing without Prescription  Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02
fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG,   For Institutional or Office Use Only--Not for Resale   Federal Law Prohibits Dispensing without Prescription  Healix Infusion Therapy, Inc.  (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478  NDC  75901-8008-33
fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG   For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription  Healix Infusion Therapy, Inc.  (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04