[Posted 05/14/2012] AUDIENCE: Risk Manager, Consumer ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed, including respiratory depression […]
Ikaria INOmax DS Drug Delivery System: Class I Recall – Erratic Nitric Oxide (NO) Readings
AUDIENCE: Pulmonology, Risk Manager ISSUE: 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. Adverse consequences may include inadequate oxygen reaching the tissues in the body (hypoxia), low […]
CareFusion AVEA Ventilator: Recall – Failure May Lead to Lack of Ventilation
AUDIENCE: Risk Manager, Anesthesiology, Critical Care ISSUE: FDA notified healthcare 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 […]
Eclectic Institute Dietary Supplements: Recall – Possible Salmonella Contamination
Include the products Gotu Kola (Centella Asiatica), Bladderwrack (Fucus Vesiculosus) AUDIENCE: Consumer ISSUE: Eclectic Institute is voluntarily recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack (Fucus vesiculosus) capsules because of potential Salmonella contamination. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail […]
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall – Failures with Lead Insulation
AUDIENCE: Cardiology, Emergency Medicine, Risk Manager ISSUE: FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of […]
CooperVision Avaira Aquaform Sphere Soft Contact Lenses: Class 1 Recall – Unintended Residue on Lenses
AUDIENCE: Eye Care, Consumer ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Aquaform Sphere contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment. BACKGROUND: Used for the correction of myopia or hyperopia in aphakic and non-aphakic persons with non-diseased eyes. […]
Mizuho OSI Modular Table Systems: Class I Recall – Reports of Patient Injury
Posted 11/09/2011] AUDIENCE: Risk Managers, Surgery, Orthopedics ISSUE: FDA notified health professionals of a Class I Recall of Mizuho OSI Modular Table Systems because of reports of patient injury related incidents. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling […]
CareFusion EnVe Ventilators: Class I Recall – Potential for Interruption of Patient Ventilation
AUDIENCE: Critical Care Medicine, Risk Manager ISSUE: FDA notified healthcare 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. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; […]
CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses
AUDIENCE: Eye Care, Consumers ISSUE: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment. BACKGROUND: Used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not […]
H & P Industries Povidone Iodine Prep Pads: Recall – Potential Microbial Contamination
Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International [UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers. [UPDATED 05/03/2011] Consumers using one of the affected First […]