8 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are eight reported to the FDA since late July:

  1. Boston Scientific recalled its Ingenio pacemakers and its CRT-Ps due to a risk of the devices transitioning to safety mode. In safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, it can't be reprogrammed and must be replaced. There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing. There have been no reports of death.

  2. SterRx recalled three lots of sodium bicarbonate, which is used to treat high potassium, irregular heartbeat and more. The lots were recalled due to waterborne microbial contamination, which could cause site-specific infections and serious systemic infections. SterRx said it hasn't received any reports of adverse events related to the recall.

  3. KVK Tech recalled two lots of its atovaquone oral suspension, a prescription drug designed to treat a type of pneumonia that is most likely to affect people with HIV. The drug was recalled after customer complaints of unusual grittiness in the product, which KVK determined was likely caused by prolonged exposure of the lots to extremely cold weather during shipment.

  4. Eco-Med Pharmaceuticals recalled several lots of its ultrasound gel after finding they were contaminated with the bacteria Burkholderia cepacia, which has caused at least 15 infections.

  5. Eight Medical International recalled its recirculator 8.0 disposable lavage kit, which is used with its hyperthermic perfusion system. The kit allows the perfusion system to circulate sterile solution inside a patient's chest or abdominal cavity to reach a target temperature during surgery. The company is recalling the kit because it may release aluminum into the fluid, potentially exposing patients to high levels of aluminum, which can be toxic and cause serious adverse events, including death.

  6. Philips recalled its V60 and V60 Plus ventilators due to a risk of the device reaching its default maximum limit, which can happen if the oxygen flow is partially blocked for any reason. For patients who need high-flow oxygen therapy, if the issue is not resolved, the ventilator will continue to provide the patient with a lower oxygen flow rate than necessary and issue a low priority alarm. There have been 61 incidents, 25 injuries and no deaths stemming from the issue.

  7. Philips recalled its continuous and noncontinuous ventilators because the foam used to reduce sound and vibration in the devices may break down and enter the device's air pathway and be inhaled or swallowed by the person using the device. There have been more than 1,200 complaints and more than 100 injuries reported for the issue.

  8. Vero Biotech recalled its nitric oxide delivery system, which is used to deliver a drug to help open blood vessels and improve oxygen levels in critically ill newborns with respiratory failure. The device was recalled due to a software issue that leads to errors in the delivery of nitric oxide, which has caused 11 complaints, three injuries and no deaths.

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