FDA Alerts

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance

Mon, 20 May 2013 13:38:00 -0500

All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility

Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

Tue, 14 May 2013 15:02:00 -0500

Zolpidem Containing Products Drug Safety Communication

The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

Thu, 09 May 2013 09:16:00 -0500

The Compounding Shop FDA News Release Lack of Sterility

Maquet SERVO-i Ventilator Battery Module: Class 1 Recall - Battery Run Time Shorter Than Expected

Wed, 08 May 2013 08:34:00 -0500

Maquet SERVOi Ventilator Battery Module Class 1 Recall Battery Run Time Shorter Than Expected

Valproate Anti-Seizure Products: Drug Safety Communication - Contraindicated for Pregnant Women for Prevention of Migraine Headaches

Tue, 07 May 2013 10:24:00 -0500

Valproate AntiSeizure Products

Cardinal Health: Class 1 Recall - Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

Tue, 07 May 2013 10:22:00 -0500

Cardinal Class 1 Recall Various Presource Kits

Hospira Inc., GemStar Infusion System: Recall - Lithium Battery Low Voltage

Mon, 29 Apr 2013 00:00:00 -0500

Hospira Inc GemStar Infusion System Recall

CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall - Communication Error When Attached to EtCO2 or SpO2 Modules

Tue, 23 Apr 2013 00:00:00 -0500

CareFusion

MedWatch March 2013 Safety Labeling Changes

Mon, 15 Apr 2013 00:00:00 -0500

Safety Labeling Changes

Spacelabs Anesthesia Workstations and Service Kits: Class 1 Recall - Defect in CAS I/II Absorbers

Tue, 26 Mar 2013 00:00:00 -0500

Spacelabs Anesthesia

Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting

Mon, 18 Mar 2013 00:00:00 -0500

Sybios

FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy

Wed, 20 Feb 2013 00:00:00 -0600

FDA Drug Safety Communication

GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems: Class 1 Recall - Potential Reversal of Oxygen/Air

Fri, 15 Feb 2013 00:00:00 -0600

GE Healthcare

Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower

Fri, 08 Feb 2013 00:00:00 -0600

Hamilton Medical

Fisher and Paykel Healthcare Reusable Breathing Circuit Class I Recall - Pinholes in Tubes

Mon, 07 Jan 2013 00:00:00 -0600

Fisher and Paykel Healthcare Reusable Breathing Circuit Class I Recall - Pinholes in Tubes

Bunnell Life Pulse High-Frequency Ventilator Patient Circuits: Recall- Melted Insulation Can Cause Sparking and Smoke

Fri, 21 Dec 2012 00:00:00 -0600

Bunnell

Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

Fri, 21 Dec 2012 00:00:00 -0600

Hydrocodone

Ventlab Adult and Pediatric Manual Resuscitators: Recall-Valve Leak Prevents Flow of Air/Oxygen to Patient

Fri, 21 Dec 2012 00:00:00 -0600

Ventlab Adult and Pediatric Manual Resuscitators

Verathon GlideScope Video Laryngoscope Reusable Blades: Class 1 Recall - Breaking Across the Tip of the Blade

Thu, 13 Dec 2012 00:00:00 -0600

Verathon

Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets

Fri, 07 Dec 2012 00:00:00 -0600

Qualitest

Ondansetron (Zofran) 32 mg, Single Intravenous (IV) Dose: Updated Safety Communication – Product Removal due to Potential For Serious Cardiac Risks

Tue, 04 Dec 2012 00:00:00 -0600

Ondansetron

Mindray A3 and A5 Anesthesia Delivery System: Class I Recall - Gasket Leak

Fri, 30 Nov 2012 00:00:00 -0600

Mindray A3 and A5 Anesthesia Delivery System

Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected

Fri, 09 Nov 2012 00:00:00 -0600

Baxter Healthcare Corp Buretrol Solution Sets

Fungal Meningitis Outbreak Laboratory results from samples of two additional recalled NECC products

Thu, 01 Nov 2012 00:00:00 -0500

Fungal Meningitis Outbreak Laboratory results from samples of two additional recalled NECC products

Ameridose, LLC: Recall of Unexpired Products in Circulation

Wed, 31 Oct 2012 00:00:00 -0500

Ameridose

Fungal Meningitis Outbreak: FDA Provides NECC Customer List

Mon, 22 Oct 2012 00:00:00 -0500

Fungal Meningitis Outbreak FDA Provides NECC Customer List

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update

Thu, 18 Oct 2012 00:00:00 -0500

FDA Statement on Fungal Meningitis Outbreak Additional Patient Notification Advised Update

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

Tue, 16 Oct 2012 00:00:00 -0500

Flowmeters for Nitrous Oxide

FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

Mon, 15 Oct 2012 00:00:00 -0500

FDA Statement on Fungal Meningitis Outbreak Additional Patient Notification Advised

New England Compounding Center (NECC): Potentially Contaminated Medication Fungal Meningitis Outbreak

Mon, 08 Oct 2012 00:00:00 -0500

New England Compounding Center Potentially Contaminated Medication Fungal Meningitis Outbreak

I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I Recall - Risk of Continuous Infusion at a Rate Greater Than Expected

Fri, 31 Aug 2012 09:10:00 -0500

I-Flow ON-Q Pump with ONDEMAND Bolus Button

CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction To Stop Infusion

Wed, 22 Aug 2012 00:00:00 -0500

CareFusion 303

Hospira Hydromorphone Hydrochloride Injection

Fri, 17 Aug 2012 00:00:00 -0500

Hospira Hydromorphone Hydrochloride Injection

Hospira Propofol Injectable Emulsion: Recall- Glass Vial Defect

Fri, 17 Aug 2012 00:00:00 -0500

Hospira Propofol Injectable Emulsion

Covidien Shiley Adult Tracheostomy Tubes: Class I Recall - Reports Of Volume Leakage And/or Disconnection Between The Inner And Outer Cannulae

Thu, 16 Aug 2012 00:00:00 -0500

Covidien Shiley Adult Tracheostomy Tubes

B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch

Mon, 13 Aug 2012 00:00:00 -0500

Braun Infusomat Space Infusion System

CareFusion Alaris PC Unit, Model 8015: Class I Recall - Error Code

Thu, 02 Aug 2012 00:00:00 -0500

CareFusion Alaris PC Unit

Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient

Tue, 31 Jul 2012 00:00:00 -0500

Multi Lumen Venous Catheterization

CareFusion EnVe Ventilators: Class I Recall - Leak In Patient Breathing Circuit or System

Fri, 20 Jul 2012 00:00:00 -0500

CareFusion EnVe Ventilators

GE Healthcare Aestiva/5 7900 Ventilator - Class 1 Recall - Potential for Unrecognized Overdose

Wed, 11 Jul 2012 00:00:00 -0500

GE Healthcare Aestiva

Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall - Device Field Correction

Wed, 11 Jul 2012 00:00:00 -0500

Maquet Medical Systems USA FLOW

CareFusion Airlife Infant Breathing Circuit: Class I Recall - Potential for Leak in Closed Ventilation System

Fri, 06 Jul 2012 16:16:00 -0500

CareFusion Airlife Infant Breathing Circuit: Class I Recall

Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

Fri, 29 Jun 2012 00:00:00 -0500

Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation

Hospira Carpuject Pre-filled Cartridges - Drug Alert: Products May Contain More Than the Intended Fill Volume

Thu, 24 May 2012 00:00:00 -0500

Hospira Carpuject Prefilled Cartridges

Hydromorphone Hydrochloride Recall

Wed, 16 May 2012 00:00:00 -0500

Hydromorphone Hydrochloride Recall

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

Wed, 18 Apr 2012 11:04:00 -0500

Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall - Defective Component

Mon, 05 Mar 2012 00:00:00 -0600

FDA notified healthcare professionals and medical care organizations of the Class 1 recall of the listed AEDs which contain a component that may fail unexpectedly due to a defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component.

Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes: Class 1 Recall - Inadvertent Dislodgement

Fri, 24 Feb 2012 08:31:00 -0600

FDA notified healthcare professionals and medical care organizations about the Class 1 recall of certain lots of these tracheostomy tubes. Difficulty arising from disconnecting accessories from the connectors of the affected tubes may result in excessive force to detach the accessory and the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Mon, 09 Jan 2012 00:00:00 -0600

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

Ikaria INOmax DS Drug Delivery System: Class I Recall - Erratic Nitric Oxide (NO) Readings

Wed, 04 Jan 2012 00:00:00 -0600

FDA notified healthcare professionals of a Class I recall of Ikaria INOmax DS Drug Delivery System. Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals.