FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for   AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read ''If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.'' The labeling for the recalled lots omits the work ''not'' in that sentence.
Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC  53489-677-07
The reason for this recall is an error in section 5.11 of the labeling that results in incorrect medical advice.  Specifically, the labeling should read ''If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated.''  The labeling for the recalled lots omits the work ''not'' in that sentence.
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC  53489-678-07), b) 90 count bottle (NDC 53489-678-90),  Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
Labeling: Incorrect Instructions: The product is being recalled due to a labeling error which provides incorrect medical advice.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Creole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA  70124, UPC:  811773014869
Product which contains milk, soy, and wheat was distributed without an ingredient statement which declares their presence.
Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems.   Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Positive bias on the lots listed compared to alternate methods and a higher frequency of ''Above Assay Range'' flags with the lots listed.
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems.   Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
US Distribution: including states of: WA and UT.
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB.   The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use with the system indicated in the model number
Serial numbers NS 10324 through NS 10392
TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand switch for GE OEC 9800/9900 and Philips FDS and FDB Cath Labs due to potential safety issue related to the use of this product producing uncommanded X-ray.
US Distribution: including states of: TX and VA.
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA,  PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***   Intended for cutting and shaping bone.
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126**   Intended for cutting and shaping bone.
***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***   Intended for cutting and shaping bone.
***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. 4500 Riverside, Palm Beach Gardens, FL 33410 USA Tel: (800) 327-6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP11 1LA United Kingdom Tel: +441494 616126***   Intended for cutting and shaping bone.
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter,   Rechargeable Lithium Batteries  Single: 46626; 4 Pack: 46827; 5 Pack: 50436.    For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
Revised Battery Instructions for Removal and Expiration  Date due to battery swelling and cell leakage
Terrain Zyme Myco-Zyme (Z-13), Enzyme-Based Herbal Dietary Supplement, packaged as 90 capsules per bottle.  Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
Innovative Labs, LLC. has recalled two Dietary Supplements due to the presence of  Chloramphenicol, an antimicrobial agent.
Terrain Zyme LGS-Zyme (Z-12), Enzyme-Based Multivitamin & Amino Acid Dietary Supplement, packaged as 120 capsules per bottle.  Distributed by Apex Energetics, Inc. 16592 Hale Avenue, Irvine CA 92606.
Triple Mix Injectable (aka Dr Ungers Triple Rx;  Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable; Dr Khoudary's Triple Rx Injectable) Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AK, AL, CA, CO, CT, FL, GA, IL, KS, MA, NC, NH, NJ, OH, OK, PA, SC, TN, TX, VA, and WI, and the countries of Australia, Canada, and  Russia.
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop'').
Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T    The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
111,504 units US and 3,638 Canada and Mexico-
2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.
EOS System X- ray beam   Digital radiography system used in general radiographic examinations.
EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.
US Distribution: including states of: AL, CA, PA, and VA.
Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device with BZO, Reditest On-Site  Oral Fluid Drug Screen Device & XALEX One Step Rapid Drug Test.    Type of Packaging: 25 individually pouched test devices & collectors in a labeled  kit box.    The OrALert'' Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP/BZO is an  immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid  specimen compete against their respective drug conjugates for binding sites on their specific antibody.
Alere initiated this recall of certain lots of the Oral Fluid Drug Scrren Device because the sponge may become dislodged from the Saliva Collector handle prior to or during the oral fluid sample collection process. If the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk.
Armanino Alfredo Sauce; Frozen in 10 oz x 12 pouches per case (sample, not for retail sale) and   3 lb. pouches 4 x 3 lb. pouches per case  for food service  use  UPC - 10 oz. samples: 10041622 002635  UPC 3 lb. pouch: 10041622 019428  Distributed by Armanino Foods, Hayward, CA;  Manufactured by Del Monaco  Specialty Foods, Walnut Creek, CA
Three lots of the 10 oz. pacakges, and 2 lots of the 3 lb. packages are under recall.  The codes for these are as follows: 10 oz. sample size: Product code: 41622 263AS: DSF Code: 960110    Package code: A26713,   Packaging Date: 09/24/13  Case code: 0924139438;    Package code: A26913  Packaging Date: 09/26/13  Case code: 0926139569;    Package code: A31113  Packaging Date: 11/07/13  Case code: 1107131625      4 x 3 lb. pouch size: Product code  41622-1942F; DSF Code 941270    Package code: Use by 9-25-14  Packaging Date:9/25/13   Case code:0925139543    Package code: Use by 11/06/14   Packaging Date: 11/06/13  Case code: 1106131577
196 cases of  12. x 10 oz, sample size;  1470 lbs; 550 cases of 4 x 3 lb.
The product was not labeled with ingredients nor with an allergen declaration; the carton only contained one label which states the product identity by the second label with ingredients and allergen information was inadvertently left off. The product is for food service and is sold in cartons of 4 x 3 lb. individual pouches and samples, not for retail sales.
Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan,  Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN.   These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications.    intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
6003 units total (1715 units in the US and 4288 outside the US)
Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
EstroPlus Maximum Strength Menopause Support Dietary Supplement in 28 count and 56 count blister strips under the following labels - CareOne Maximum Strength  Multi Symptom Menopause Formula, 28 Caplets/Dietary Supplement; Meijer Maximum Strength Estroplus, Dietary Supplement, 28 Caplets; TopCare Maximum Strength Estroplus Dietary Supplement, 28 Caplets; Sunmark Estroplus Extra Strength, Dietary Supplement, 56 Caplets; Health Mart Pharmacy Extra Strength Estroplus, 56 Caplets Dietary Supplement; Up&Up Estroplus Dietary Supplement Maximum Strength 28 Caplets; CareOne Extra Strength Estroplus 56 Caplets/Dietary Supplement; Western Family Extra Strength Estroplus 56 Caplets, Meijer Extra Strength Estroplus Dietary Supplement 56 Caplets; Publix Extra Strength Estroplus 56 Caplets, Dietary Supplement; and TopCare Extra Strength Estroplus Dietary Supplement 56 Caplets.
Potential presence of Chloramphenicol contamination
Worldwide Distribution: US (nationwide) including states of:  AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK,  PA, PR, RI, TN, TX and WI; and country of: Canada.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    A manual surgical scalpel blade for making incisions in various general surgical procedures.
510 K exempt Device Listing Number D129456  Model Number 2210-N  LN 0563 Jan 2016  LN 2263 Jul 2016
50 cases (4800 units); 96 cases (576 units)
Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    A manual surgical scalpel blade for making incisions in various general surgical procedures.
510 K exempt Device Listing Number D129456  Model Number 2211-N  LN 2782 9/2015  LN 1413 4/2016  LN 1623 5/2016
15 cases (1440 units); 96 cases  (96 units); 96 cases (2880 units)
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    A manual surgical scalpel blade for making incisions in various general surgical procedures.
510 K exempt Device Listing Number D129456  Model Number 2210-L   1) LN 0662 2/2015  2) LN 2052 6/2015
13 cases (312 units); 24 cases (1176 units)
510 K exempt Device Listing Number D129456  Model Number 2211-L LN 2962
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    A manual surgical scalpel blade for making incisions in various general surgical procedures.
510 K exempt Device Listing Number D129456  Model Number 2215-N LN 1203 and 1553
Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    2215-L Weighted Safety Scalpel, #3L Handle (8.75) with #15 Blade, Yellow Shield with TIME OUT Sleeve (S) 12 per box; 8 boxes per case (96 total scalpels)    A manual surgical scalpel blade for making incisions in various general surgical procedures.
510 K exempt Device Listing Number D129456  Model Number 2215-L LN 2052
Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    A manual surgical scalpel blade for making incisions in various general surgical procedures.
510 K exempt Device Listing Number D129456  Model Number 2220-N LN 1793
Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX.  Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.
Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only  Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA  NL 850-1121    Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type package were found prior to use but after the sterile package was open
Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only  Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Made in the USA  NL 850-1132    Provides access to the lateral cerebral ventricles via hypodermic puncture. It is useful in obtaining CSF (cerebral spinal fluid_ samples for cytological and chemical studies, for monitoring ventricular fluid pressure and for ventricular drainage. The reservoir provides easy access to the lateral ventricles and to cystic tumors for the injections of chemotherapeutic agents and/or radio-isotopes. The rickham reservoir may be utilized in hydrocephalic patients as a component in systems designed to shunt CSF from the lateral ventricles into either the right atrium of the heart of the peritoneum.
Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.
Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe,  1.0ml 29g x 1/2 in Reference: 4429-1    Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe,  0.3ml 29g x 1/2 in Reference: 4429-3    Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe,  0.5ml 29g x 1/2 in Reference: 4429-5    Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe,  1.0ml 29g x 1/2 in Distributed by:  Cardinal Health, Dublin, OH (Co-Brand)  Reference: ED012905-IN    Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe,    0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN    Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Safeway Kitchens In Shell Edamame; Net Wt: 48 oz. (3 lb, 1.35Kg)  12 x 3 lb bags per case:  Product of China:  Packed in Canada    Safeway, Pleasanton, CA.
Best before May 21, 2015: Packed on November 21, 2013:  UPC: 0 21130 09197 3
Product on hold pending FDA testing that found 0.015 ppm of the pesticide chlorafluazuron was inadvertently released to Safeway warehouses and a few retail stores.
REF 42-411571  QTY 1 CATALOG  CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE  M PKA GDE/MDL SET SML-MP  DD.....R-FEB55RKA-T JA-A01 05551  PKA POST CUT SML-PKA MICROPLASTY  CUSTOM-MADE DEVICE  non-sterile    The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Stryker Instruments Div. of Stryker Corporation
US Distribution: including states of: MI, OH, and TX.
Stryker Color Cuff, REF 5921-034-135  Disposable Tourniquet Cuffs  34 in x 4 in (86 cm x 10 cm)  Single Bladder, Single Port, QuickConnect  Rx only, STERILE
The Color Cuff Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may  lead to an inoperable system due to incompatibility with the Smart Pump.
IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap
IMT Wellness Tribulus Supreme 2.0** GI & Immune Support ** Dietary Supplements 60 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT
Worldwide Distribution - USA including TX, NY, PA, and TN.  Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.
Aesculap Hi-Line XXS handpiece   Hi-Line XXS handpieces are used with the HiLAN and microspeed motor systems to hold burrs which cut and shape bone.
Certain lots of the Aesculap Hi Line XXS handpiece (part # GB790R) were recalled due to a possible failure of the handpiece.
Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.
Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
A sharp edge on the cannulated tip of the device may damage or cut a suture.
Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
C-Plus'' 10mm x 12mm Webless implants   Pioneer Surgical's C-Plus '' 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.
As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR).  While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a slightly greater chance for subsidence or expulsion.
Worldwide Distribution - USA (nationwide) and Internationally to Austria, Estonia, Belgium, Spain, Italy, Poland, Bulgaria, Finland, Portugal, Switzerland, France, Lithuania, Romania, Cyprus, Great Britain, Czech Republic, Greece, Latvia, Slovenia, Germany, Hungary, Slovak Republic, Ireland, Netherlands, Turkey, Croatia, Andorra, Albania, Algeria, Bahrain, Bosnia and Herzegovina, Egypt, Georgia, Iran, Iraq, Israel, Jordan, Kenya, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Morocco, Russia, Saudi Arabia, Serbia, South Africa, Syria, Sudan, Tunisia, UAE, Uganda, Puerto Rico, Mexico, Columbia, Chile, Brazil, Argentina, Uruguay, Panama, Costa Rica, Peru, China, Korea, Japan, Taiwan, Hong Kong, Malaysia, Singapore, Sri Lanka, Australia, New Zealand.
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG.   The intended use of the product is to provide mechanical ventilation to patients.
Software Part number 4-070212-85, revision AB-AG
Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.
Hood brand  Fat Free Chocolate Milk, 8 oz. UPC: 0 44100 11244 7
Sell by Date: DEC 31 2014 xx:xx  42-207 L1
Product labeled with an extended sell by date
Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, Great Britain, France, Sweeden, Italy, Spain, Japan, South Africa, Australia, Switzerland,
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT,   MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,   MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM,   MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM,   MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM,   MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM,   MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,   MCA5-1SB - lMM FLUTED BALL, 5.6CM,   MCA5-1SD - lMM DIAMOND BALL, 5.6CM,   MCA5-2SB - 2MM FLUTED BALL, 5.6CM,   MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,   MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,   MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,   MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,   MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,   MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,   MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,   MCA7-1SB - lMM FLUTED BALL, 7.3CM,    MCA7-1SD -  1 MM DIAMOND BALL, 7 .3CM,    MCA7-2SB - 2MM FLUTED BALL, 7.3CM and   MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.    The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
All Lots for  MCA - MICRO CURVED ATTACHMENT,   MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,   MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM,   MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM,   MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM,   MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM,   MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM,   MCA5-1SB - lMM FLUTED BALL, 5.6CM,   MCA5-1SD - lMM DIAMOND BALL, 5.6CM,   MCA5-2SB - 2MM FLUTED BALL, 5.6CM,   MCA5-2SD - 2MM DIAMOND BALL, 5.6CM,   MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM,   MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM,   MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM,   MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM,   MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM,   MCA7-15SD  1.5MM DIAMOND BALL, 7.3CM,   MCA7-1SB - lMM FLUTED BALL, 7.3CM,    MCA7-1SD -  1 MM DIAMOND BALL, 7 .3CM,    MCA7-2SB - 2MM FLUTED BALL, 7.3CM and   MCA7-2SD - 2MM DIAMOND BALL, 7.3CM.
During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs.  The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy.  The use of the device in dense bone removal may result in cutter/burr fracture.
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control).   Cutting and shaping bone.
Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.    Cutting and shaping bone.
On Site Gas Systems POGS 33C Portable Oxygen Generation System
Heat exchanger hose becomes weak and may fail.
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24'' seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035   For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
The wheels on Tracer IV wheelchairs (Tracer IV 24'' seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
En-route to one location in Sarasota, FL.
Organic Almonds: Baugher Ranch Organics;  Certified Organic by California Organic Farmers  May Contain occasional Shell fragments.  Keep Refrigerated; 25 lbs.    Baugher Farms, Orland, CA
Lot number BR08-13A23-1333803; Expiration date June 2015
Potential for metal fragments in product after a single wire from metal detector was confirmed to be cut into fragments and not all pieces are accounted for.
Worldwide Distribution: US (nationwide) including states of: TX, NC, OH, IA, UT, KY, ME, CA, NY, MA. NJ, IL, PA,, TN, FL, MO, GA, HI, SC, NE, MI, and GA and  countries of: Dominican Republic, Germany, Switzerland, Australia, Spain, Japan, United Kingdom, Canada, France, The Netherlands, Austria, and Singapore.
Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I    200-240V ~, 50/60 Hz, 15A,  (2) 15A Resettable CB:  Tested and complies with FCC Part 15 Class A.    OptiMedica  1310 Moffett Park Drive  Sunnyvale, CA 94089    The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf mat, which may manifest an odor and visible smoke.
Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, O, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR,PA PR, RI,SC, TN, TX, UT, VT, VA, WA, WI, and WY. Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON,LITHUANIA, MALAYSIA, MAURITIUS, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR , SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
GE Healthcare has recently become aware of a potential safety issue which affects all Patient  Date Modules produced from April 2007 through June 2010, encompassing Fiscal Week 13, 2007 through 26, 2010 due to fluid ingress into the top cover assembly which can result in heat buildup.
Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC,  and Internationally to CA, BE, IN, KW, and AU.
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769   The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.
6'' (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
183 cm (72'') Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave  , NanoClave T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
184 cm (72'') Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave, NanoClave TConnector,  Rotating Luer, Part No. A1000, Item No. 011-A1095  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
31 cm (12'') Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave TConnector,  Rotating Luer, Part No. A1000, Item No. 011-A1097  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. A1001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer, Part No. A1000, Item No. A1007  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
8'' (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
78'' Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave T-Connector, 4 Clamps, Rotating  Luer, 3 Ext, Part No. A1000, Item No. A1026  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
11'' Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave'', 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
8'' (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave'', 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
8'' Smallbore Pentafuse Ext Set w/5 NanoClave'', 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
10'' Smallbore Pentafuse Ext Set w/5 NanoClave'', 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
87'' (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave, Part No. A1000, Item No. A1078  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
13'' Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer,  Part No. A1000, Item No. A1080  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
14'' (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rotating Luer,  Part No. A1000, Item No. A1081  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
103'' (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave'', Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock,  Part No. A1000, Item No. A1093  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
8'' Ext Set w/NanoClave'' Stopcock, Clamp, Rotating Luer,  Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave'' TConnector, Rotating Luer,  Part No. A1000, Item No. K7084-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave'' TConnector w/Luer Slip,  Part No. A1000, Item No. K7085-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave'', Clamp, Rotating Luer,  Part No. A1000, Item No. K7088-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.anoClave'', Clamp, Luer Lock,  Part No. A1000, Item No. K7089-001
7'' (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave'' T-Connector, Clamp, Rotating Luer,  Part No. A1000, Item No. K7090-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
10'' (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave'' T-Connector, 4 Clamps (Red, White, Blue),  Rotating Luer,  Part No. A1000, Item No. K7091-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
106'' (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave'' TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock,  Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
78'' Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave'' T-Connector, 4 Clamps, Rotating Luer, 3 Exts,  Part No. A1000, Item No. K7094-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave'', Clamp, Luer Lock, Part No. A1000, Item No. K7095-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave'', 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave'', 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
10'' (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
10'' (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave'', Clamp, Luer Lock, Part No. A1000, Item No. K7102-001    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
7'' (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
11'' Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave'', 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
13'' Pentafuse Smallbore Ext Set w/NanoClave'', 1.2 Micron Filter, 3 MicroClave Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
8'' (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave'', 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
30'' (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 1  Ext, Part No. A1000, Item No. SC124    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
120'' 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating  Luer, 2 Ext, Part No. A1000, Item No. SC125    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
5'' (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave'', Clamp, Rotating Luer, Part No. A1000, Item No. Z3845    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
5'' Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358.    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
5'' Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243.   The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
5'' Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244.    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
28'' (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245.    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6.5'' (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, NanoClave T-Connector,  Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393.    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
6'' (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave T-Connector, Rotating Luer, Item # A1003, Lot # 2773812.    The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
17 cm (7'') Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668.  The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA.  Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
Presence of Foreign Substance; metal particulates were visually observed in tablets.