FDA announces multiple Class 1 recalls

Editor's Note

The US Food and Drug Administration (FDA) designated Class 1 Recalls—the most severe category indicating serious risk of injury or death—for multiple devices over the past few days, including pressure monitoring systems, emergency resuscitators, fluid delivery sets, extracorporeal blood circuits, endoscope accessories, infusion pumps, and glucose/Ketone meters. These recalls include the following:

• Becker's External Drainage and Monitoring System and Exacta External Drainage and Monitoring System (EDMS), recalled by the Medtronic Neurosurgery due to risk for cracks and/or leaks in device stopcocks that could cause infection or death. 15 injuries and no deaths have been reported.
• Mercury Medical T-Piece Resuscitator (Neo-Tee) from Mercury Enterprises Inc., which is recalling the devices due to a small spring in the controller that may prevent effective ventilation and result in desaturation, bradycardia, hypoxia, hypercarbia, and death. There have been no reported injuries or deaths.
• Medline has issued a letter recommending the removal of certain lots of Fluid Delivery Sets with Drip Chamber within Medline custom kits. The offending systems were incorrectly assembled, resulting in the risk of over-administration of fluids and edema, shortness of breath, increased blood pressure, and death. No injuries or deaths have been reported. 
• Newellis recommends certain lots of AquaFlexFlow UF 500 Plus extracorporeal blood circuits be removed from use due to the risk of weight mismatch alarms terminating therapy and causing excess fluid removal. This can result in hypovolemia, a particularly serious condition in pediatric patients. The company has reported three injuries.
• Olympus recommends the removal of the forceps/irrigation plug accessory for certain endoscopes due to contamination from improper and/or incomplete reprocessing. Risks include infection, urinary tract infection, sepsis, and death. Olympus has reported 120 injuries and one death.
• Trokamed Mini PCNL sheaths are not to be used for suction and irrigation, the company announced, citing lack of clarity in original instructions. Using the devices for suction or irrigation could result in built up pressure and kidney rupture. One death has been reported.
• A subset of Fresenius Kabi USA’s Ivenix large-volume pumps are to be removed and repaired due to increased chance of issuing a non-recoverable pump problem alarm. This failure could potentially delay or interrupt therapy, resulting in permanent disability or death. No injuries or deaths have been reported.

The full FDA report offers additional details on each recall as well as advice for users.