AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine ISSUE: 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 […]
Octopus Nuvo Tissue Stabilizer: Recall – Potential for Device Fracture
AUDIENCE: Risk Manager, Surgery ISSUE: Medtronic informed healthcare professionals of a recall of the Octopus Nuvo Tissue Stabilizer due to the potential that a component of the device could fracture during use. The resulting potential hazards are that fragments of the component could fall into the patient’s chest cavity and/or damage the heart tissue. Medtronic […]
Fentanyl Transdermal System: Recall – Potential for Active Ingredient to Release Faster Than Specified
AUDIENCE: Pharmacist, Anesthesia ISSUE: FDA notified healthcare professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). BACKGROUND: Fentanyl […]
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall – Potential Loss of Sterility
AUDIENCE: Risk Manager ISSUE: Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead […]
CareFusion Corporation Alaris PC Units (Model 8015): Recall – Potential for Delay or Interruption of Therapy
AUDIENCE: Risk Manager ISSUE: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot […]
Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns
AUDIENCE: Dentistry ISSUE: FDA is again alerting healthcare professionals and dental organizations of a safety issue described in a 2007 Public Health Notification, “Patient Burns from Electric Dental Handpieces”. These devices are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. These burns range from first degree […]
BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall
AUDIENCE: Risk Manager, Emergency Medicine ISSUE: Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment […]
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall
AUDIENCE: Risk Manager ISSUE: Potential for the device to fail to detect air in line at the end of an infusion. Failure to detect air in line may result in the delivery of air to the patient, resulting in serious injury or death. BACKGROUND: The Symbiq Infusion System is an infusion pump intended for the […]
AngioSculpt “EX” PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall – Risk of Catheter Separation
AUDIENCE: Cardiology, Risk Manager ISSUE: The AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. This recall includes all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003. This product was distributed […]
Huber Needles: Recall – Risk of Coring
Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing Huber Needles Infusion Set Needles [Manufactured by Nipro for Exelint] [Posted 08/26/2010] AUDIENCE: Risk Manager, Surgery, Critical Care Medicine ISSUE: FDA notified healthcare professionals of the Class I Recall of certain Huber needles […]