5 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are five reported to the FDA in August:

  1. Cardinal Health recalled 267 million monoject flush prefilled saline syringes after finding the punger may pull back and reintroduce air into the syringe, which can cause serious adverse outcomes. Cardinal has received 37 reports of the plunger pulling back, but no injuries were reported as of Aug. 19.

  2. Bio-Medical Equipment Services recalled its Alaris infusion pump model 8100 after finding the bezel components may crack or separate, leading to inaccurate delivery of fluids to patients, which could cause serious patient harm. The Alaris pump is used to deliver fluids such as medications, nutrients and blood to a patient in controlled amounts. There have been no deaths, complaints or injuries reported for the recall.

  3. Cardinal Health recalled its Argyle UVC insertion tray, which is used during a procedure for critically ill newborns, after finding it doesn't include specific instructions about the scalpel's permanent locking feature. The scalpel has been linked to two patient deaths, but the causes of death haven't been established as being the result of the device.

  4. Pfizer recalled four more lots of its smoking cessation drug Chantix after finding some pills contain elevated levels of nitrosamines, a likely carcinogen.

  5. Baxter Healthcare recalled its Dose IQ safety software, which allows providers to create a drug library of preprogrammed dosing information for specific medications delivered using the Spectrum IQ infusion pump. Baxter is recalling the software after finding a defect that may lead to mismatched drug information in the drug libraries. If the software's drug identifier doesn't match the information in the pump, the drugs may be improperly configured and cause serious adverse events, including delay in therapy, under-infusion or over-infusion of the drug. There have been 15 complaints reported for the issue, but no injuries or deaths.

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