FDA Alerts

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.

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Thu, 12 Jan 2012 14:41:00 -0600

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Thu, 12 Jan 2012 00:00:00 -0600

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

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.

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

Fri, 23 Dec 2011 00:00:00 -0600

FDA notified health care professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death.

CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation

Fri, 04 Nov 2011 00:00:00 -0500

FDA notified health care professionals of a Class I recall of all EnVe Ventilator model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient.

Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms

Thu, 15 Sep 2011 00:00:00 -0500

FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics).

Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance

Mon, 12 Sep 2011 00:00:00 -0500

Medtronic and FDA notified healthcare professionals of a Class I recall of the SynchroMed II Infusion system. Medtronic’s analysis of the problem indicates it is related to the formation of a film within the pump battery. This problem can lead to the sudden loss of therapy and the return of underlying symptoms and/or therapy withdrawal symptoms.

GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall

Wed, 03 Aug 2011 00:00:00 -0500

FDA notified healthcare professionals of a Class I recall of GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits. The HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.

Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled

Mon, 27 Jun 2011 13:11:00 -0500

Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone.

Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets

Mon, 27 Jun 2011 12:50:00 -0500

Endo Pharmaceuticals and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg because some bottles may contain different strength tablets, resulting in patients taking more than the intended acetaminophen dose.

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

Tue, 07 Jun 2011 09:57:00 -0500

Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

Tue, 10 May 2011 00:00:00 -0500

Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.

Needleless Pre-Filled Glass Syringes: Drug Safety Communication - Compatibility Problems With Needleless Intravenous Access Systems

Fri, 06 May 2011 00:00:00 -0500

The FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, if possible. The use of needleless pre-filled glass syringes in emergency situations should be avoided.

Cook Inc., Central Venous Catheter Trays

Thu, 03 Mar 2011 00:00:00 -0600

FDA notified healthcare professionals of leaks in the plunger luer detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility. This may lead to serious adverse health consequences and/or death.

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

Thu, 13 Jan 2011 00:00:00 -0600

FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose

Mon, 10 Jan 2011 17:12:00 -0600

Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product.

Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials

Mon, 03 Jan 2011 00:00:00 -0600

The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. "read more"

Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials

Wed, 29 Dec 2010 00:00:00 -0600

American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials because some vials of these lots contain particulates. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.

Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product

Fri, 24 Dec 2010 00:00:00 -0600

American Regent and FDA notified healthcare professionals of the nationwide recall of specific lots of Dexamethasone Sodium Phosphate Injection, USP 4 mg/mL, 30 mL Multiple Dose Vial because some vials of these lots either contain particulates or have the potential to form particulates prior to their respective expiration dates.

Propoxyphene: Withdrawal - Risk of Cardiac Toxicity

Fri, 19 Nov 2010 00:00:00 -0600

FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products remove their products as well.

Needleless Pre-Filled Glass Syringes: Stakeholder Advisory - Compatibility Problems With Needleless Intravenous Access Systems

Wed, 17 Nov 2010 14:03:00 -0600

FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems.

Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures

Thu, 04 Nov 2010 13:05:00 -0500

FDA and Hospira notified healthcare professionals of a Class 1 recall of these infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates.

Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified

Fri, 22 Oct 2010 00:00:00 -0500

Fentanyl Transdermal System Recall

Ikaria® Recalls INOMAX® DS Drug-Delivery System

Wed, 25 Aug 2010 00:00:00 -0500

Ikaria® Recalls INOMAX® DS Drug-Delivery System

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

Mon, 02 Aug 2010 00:00:00 -0500

Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

Mon, 02 Aug 2010 00:00:00 -0500

NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Thu, 22 Jul 2010 00:00:00 -0500

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Fri, 09 Jul 2010 00:00:00 -0500

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

Fri, 02 Jul 2010 00:00:00 -0500

Class I Recall Due To Power Supply Failure

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

Fri, 02 Jul 2010 00:00:00 -0500

LIFEPAK 20 and LIFEPAK 20e External Defibrillator

Hospira Brand Liposyn and Propofol: Recall - Injectable products may contain particulate matter

Thu, 10 Jun 2010 00:00:00 -0500

Hospira Brand Propofol and Liposyn Products

Hospira Brand Liposyn and Propofol: Recall - Injectable products may contain particulate matter

Sun, 06 Jun 2010 00:00:00 -0500

Hospira Brand Liposyn and Propofol

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

Thu, 13 May 2010 00:00:00 -0500

GE Healthcare Aisys and Avance Anesthesia Systems: Recall

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

Fri, 07 May 2010 00:00:00 -0500

Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

Wed, 05 May 2010 00:00:00 -0500

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

Baxter Colleague Infusion Pumps: FDA Ordering Recall

Tue, 04 May 2010 00:00:00 -0500

Baxter Colleague Infusion Pumps: FDA Ordering Recall

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

Sat, 24 Apr 2010 00:00:00 -0500

Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

Thu, 22 Apr 2010 00:00:00 -0500

LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Wed, 10 Feb 2010 00:00:00 -0600

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Centurion Medical Products Premie Pack and Meconium Pack Recall

Wed, 04 Nov 2009 00:00:00 -0600

Centurion Medical Products Premie Pack

American Regent Voluntarily Recalls All Lots of Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials

Thu, 22 Oct 2009 00:00:00 -0500

American Regent Voluntarily Recalls All Lots of Ketorolac

Cardiac Science Powerheart and CardioVive AEDs: Initial Communication - Defective components may cause affected devices to not deliver electric shocks

Tue, 20 Oct 2009 00:00:00 -0500

Cardiac Science Powerheart and CardioVive AEDs

Medical Device Power Cords Safety Investigation: Initial Communication

Mon, 19 Oct 2009 00:00:00 -0500

Medical Device Power Cords Safety Investigation

Local Anesthetics, Continuously Infused (bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) : Chondrolysis reported with continuous intra-articular infusions via elastomeric infusion devices

Tue, 13 Oct 2009 00:00:00 -0500

Local Anesthetics Continuously Infused

External Biphasic Defibrillators: Initial Communication- 14 events reported in which 200 J biphasic defibrillator was ineffective in providing fibrillation/cardioversion therapy

Sat, 10 Oct 2009 00:00:00 -0500

External Biphasic Defibrillators