Current Anesthesia Related Recalls

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Current Anesthesia Related Recalls

Drug Recalls

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified, April 30, 2013 (New)
Voluntary Nationwide Recall of 15 Lots of Piperacillin and Tazobactam for Injection, USP 40.5 Grams Due to Possibility of Precipitation / Crystallization in IV Bag or IV Line Upon Reconstitution, April 29, 2013 (New)
Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 100 ML, Flexible Containers Due to Particulate, April 26, 2013
Balanced Solutions All Sterile Compounded Products: Recall - Lack of Sterility Assurance, April 22, 2013
ApothéCure, Inc. Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns, April 15, 2013
Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns, April 10, 2013
Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns, April 5, 2013
Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container: Recall - Brass Particulates, April 1, 2013
Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination, March 26, 2013
Clinical Specialties Compounding Pharmacy Products: Recall - All Sterile Products Recalled Due To Lack of Sterility Assurance, March 18, 2013
Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination, March 16, 2013
Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injecton Due To Mold Contamination, March 16, 2013
Voluntary Product Recall Initiated by Qualitest Pharmaceuticals Impacts Three Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg Repackaged and Distributed by Mylan Institutional, December 21, 2012
Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10 Mg/500 Mg Due to the Potential for Oversized Tablets, December 7, 2012
Atorvastatin Calcium Tablets by Ranbaxy Inc.: Recall - Presence of Foreign Substance, November 28, 2012
Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc.: Recall - Presence of Particulates, November 28, 2012
Questions and Answers from the FDA about the Ameridose Recall, November 1, 2012
Ameridose Issues Recall of All Products, October 31, 2012
New England Compounding Center Product Recall Information, October 7, 2012
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 Ml, Flexible Containers: Recall - Mold Contamination, October 5, 2012

Medical Device Recalls

Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected, May 7, 2013 (New)
Medtronic: Class 1 Recall - Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit, May 7, 2013 (New)
Cardinal Health – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit, May 7, 2013 (New)
Hospira Inc., GemStar Infusion System - Damage from Battery Leakage, May 1, 2013
Engineered Medical Systems, Inc., SealFlex Single Port Ribbed Mask (Infant), April 23, 2013
CareFusion Corporation, Alaris PC Unit (Model 8015) with Software Version 9.12, April 22, 2013
Covidien Issues Voluntary Recall of Power Pac Batteries for Newport™ HT70 and HT70 Plus Ventilators, April 18, 2013
BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms, April 9, 2013
Spacelabs Medical, Inc., Spacelabs Anesthesia Workstations and Service Kits, March 26, 2013
Symbios Medical Products, LLC, GOPump Elastomeric Infusion PumpKit, Part Number 510076, March 19, 2013
GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems, and the Giraffe and Panda Bag and Mask Resuscitation Systems, February 15, 2013
Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower, February 7, 2013
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility, January 28, 2013
Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes, January 7, 2013
Praxair, Inc. has Initiated a Voluntary Recall Affecting Grab‘n Go^® Vantage Portable Oxygen Cylinder Units, January 3, 2013
GE Healthcare T-Piece Circuits for the Giraffe and Panda Resuscitation Systems: Class I Recall – Failure to Achieve the Desired Inspiratory Pressure During Ventilation, December 28, 2012
Ventlab Adult and Pediatric Manual Resuscitators: Recall-Valve Leak Prevents Flow of Air/Oxygen to Patient, December 21, 2012
Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall- Melted Insulation Can Cause Sparking and Smoke, December 21, 2012
Medtronic SynchroMed II Implantable Drug Infusion Pump and SynchroMed EL Implantable Drug Infusion Pump, December 21, 2012
Ethicon, Inc., SURGIFLO Hemostatic Matrix and SURGIFLO Hemostatic Matrix Kit Plus FlexTip with Thrombin: Class I Recall - Potential for Packaging Breach, December 14, 2012
Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall - Control Screen Freezes During Treatment, December 12, 2012
Verathon, Inc., Certain GlideScope Video Laryngoscope Reusable Blades, November 30, 2012
Mindray A3 and A5 Anesthesia Delivery System: Class I Recall - Gasket Leak, November 30, 2012
HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall - Device May Intermittently Turn On and Off, November 19, 2012
Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected, November 8, 2012
Touchscreen for Hospira Symbiq Infusion System, Models 16026 and 16027, October 26, 2012
Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off, October 16, 2012

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