Recalling Firm
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Stryker Medical Division of Stryker Corporation
Stryker Instruments Div. of Stryker Corporation
Penrose-St Francis Health Services Blood Bank

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Canada, China, Italy, Germany, Greece, Kuwait, Spain, South Africa, and United Arab Emirates.
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
Product was shipped to the following states: Nationwide including Puerto Rico. Product was also shipped to the following countries: Algeria, Argentina, Bangladesh, Belgium, Brazil, Canada, France, Greece, Hong Kong, Indonesia, Italy, Japan, Malaysia, Netherlands, Pakistan, Peru, Phillipines, Saudi Arabia, Singapore, Sweden, Turkey, United Arab Emirates, United Kingdom & Venezuela.
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada, Albania, Argentina, Australia, Bosnia Herzeg., Brazil, Chile, Colombia, Egypt, Georgia, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Japan, Kazakhstan, Lebanon, Malaysia, New Caledonia, Oman, P.R. China, Pakistan, Philippines, Qatar, Rep. of Yemen, Republic Korea, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, Taiwan, Thailand, U.A.E., Ukraine, Venezuela, Vietnam, Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.
Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France
Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.
Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Nationwide Distribution-including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, 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, TN, TX, UT, VA, VT, WA, WI & WV.
Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.
US Distribution including the states of FL and MO.
AR, LA, TN, TX, IL, GA, OH, IN, NC, VA, MO, FL
Worldwide Distribution - USA including Oregon and Internationally to Australia.

Product Description
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Latex Dental Dams labeled as Non-Latex Dental Dams
Rejuvesol Red Blood Cell Processing Solution, 50 ml. Sterile Rx Intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC}. Part Number: 7012
KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 5.
STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
STRONG & KIND Roasted Jalapeno Almond Protein Bar, 45g, packaged in a green, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
STRONG & KIND Honey Mustard Almond Protein Bar, 45g, packaged in a yellow, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
STRONG & KIND Thai Sweet Chili Almond Protein Bar, 45g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12.
Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6.
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator.
Blood and Blood Products for Reprocessing
Traditional Hummus sold under the Archer Farms brand and packaged in either a transparent plastic tub or a white plastic tub with a net weight respectively of 10 oz (283 g) or 2 lb.
Roasted Garlic Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).
Roasted Red Pepper Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz).
Chipotle Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g).
Garlic Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g).
Edamame Hummus sold under the Trader Joe's brand and packaged in a transparent plastic tub with a white lid and with a net weight of 8 oz (227 g).
5 Layer Fiesta Dip sold under the Trader Joe's brand and packaged in a transparent plastic tub with a net weight of 11.5 oz (326 g) or 24 oz.
Spicy Yellow Lentil Hummus sold under the Eat Well Embrace Life brand and packaged in a transparent plastic tub with a net weight of 10 oz.
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us.
Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011, N DC #642036014141 in a sealed glass jar.
Medi-Temp Blood/Fluid Warming Cassette, Stryker Medical, 3800 E. Centre Avenue, Portage, MI 49002
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.
Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades.
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Simply Enjoy Chocolate Chip Walnut Cookies, 7oz.
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.
Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2.
MuscleTech Amino Build, Fruit Punch flavored, Net Wt. 0.58 lbs (261g) UPC 31646-70392 and Net Wt. 0.96 lbs (435g) UPC 31656-70479
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8. dental implant component.
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Red Blood Cells Leukocytes Reduced Irradiated
Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7
Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10
Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing.
Transpac IV Trifurcated Monitoring Kit w/84'' Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.

Code Info
Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
Lot Code/Exp. Date: J13026A December 31, 2015;
All products with the ''Use By'' date of JUN/11/2014
All products with the ''Use By'' dates of JUN/9/2014 and JUN/12/14
All products with the ''Use By'' date of JUN/12/2014
All products with the ''Use By'' dates of MAY/7/2014 and MAY/14/14
All products with the ''Use By'' dates of APRIL/28/2014, APRIL/29/14, and MAY/9/14
All products with the ''Use By'' dates of APRIL/15/2014,
All products with the ''Use By'' dates of JUN/10/14 E and JUN/12/14 E
Product Code: 5002-0500; Software Versions, 1.4 and 1.6
Serial Numbers: 20810001 through 20810148
ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE; 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE; 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE; 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE; 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR); 6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR); 7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR); 8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED; 9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC; 10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4; 11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4; 12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R; 13) 49973B ET DATA PREP / REVIEW SYSTEM; 14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY; 15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED; 16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
Product Code: 76730, Lot number: 307505.
Use by date Nov 5 2014, UPC # 688267135132, lot#140509AR. This product was on SO#27571. DPI ref-32722125
Serial Numbers J36000101 - J36000806 (J Numbers are analogous to Serial Numbers and for VITROS 3600 systems the J Numbers start with 3600XXXX)
Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers, for VITROS 4600 systems the J Numbers start with 4600XXXX)
Serial Numbers J56000110 - J56001954 (J Numbers are analogous to Serial Numbers, for VITROS 5600 systems the J Numbers start with 5600XXXX)
Part numbers X079-0096 and X079-0097 with Lot #12320

Product Quantity
A total of 5-pieces of each part number distributed

Reason for Recall
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.
Rejuvesol Red Blood Cell Processing Solution, with a potentially compromised container closure seal, was distributed.
The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars
Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition.
A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the ''Up'' or ''Down'' control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
Blood product, incorrectly determined to be negative for the Jk(a) antigen, was distributed.
Blood product, collected from a donor who had no responses to medical history questions documented, was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor whose health history was inadequately determined, were distributed.
Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes.
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Beirut Lift Turnip Pickles contains undeclared FD & C Red #40 and unallowable dye 45170 Rhodamine B - Basic Violet 10.
Blood/Fluid Warmer Cassettes, associated with complaints in regards to malformed threads on the female luer fitting of specific models, were distributed.
Carestream manufacturing identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling. The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. This issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. The result is the image orientation will be rotated 180 degrees.
Potential for demographic information and test result to be mismatch.
Risk of incorrect results from samples prepared with Panthera-Puncher 9
A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as ''failed'' without any other indication of failure. There are no reported injuries from the devices.
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green ''OK'' icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.
Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.
Product is not approved or authorized for distribution in the US.
Recent tests show that the ''Simply Enjoy Chocolate Chip Walnut Cookies'', Use by date Nov 5 2014, contain undeclared Macademia Nuts which could run the risk of serious or life-threatening allergic reaction if consumed by an individual with an allergy or severe sensitivity.
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Milk Specialties Global is recalling 2 lots of MuscleTech Amino Build Fruit Punch due to potential cross contamination with egg protein.
Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state ''03.7 x 8mm'' instead of ''04.7 x 8 mm.''
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed.
Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Elevated yeast level with likelihood of premature spoilage.
Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Microbial Contamination of Non-Sterile Product
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.