Insulet said its long-troubled Billerica, MA, manufacturing plant is back on track on an earnings call earlier this month--just before the FDA offered details on the OmniPod recalls that were caused by inadequate standards compliance. In July, the company issued a voluntary recall of more than 400,000 OmniPod Insulin Management Systems, which are wearable insulin pumps.
The FDA recently deemed corrective actions to three devices as Class 1, reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
CareFusion is recalling 7,418 units of its Alaris Syringe infusion pump, a corrective action that the FDA just deemed Class 1. This marks CareFusion's ninth Class 1 recall of an Alaris device since 2010, according to the database.
Northwest Farm Food Cooperative has issued a voluntarily recall of frozen raw cat food that may be contaminated with salmonella, which can affect the animals consuming the product and poses a risk to humans handling the product.
Medtronic disclosed difficulties with almost 2,000 units of its latest model insulin pump, the MiniMed 640G, which had been distributed in 10 European countries, according to a recall notice just made by the FDA. This model had its European launch in January and is slated for a PMA submission later this year.
The FDA dubbed Western Enterprises' Oxytote Oxygen System regulators potentially deadly, deeming the corrective action of its device a Class 1 recall, reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Hamilton Medical is facing another software-based recall of its ventilators, after having a similar issue in 2013. This time around, the private ventilator care company recalled almost 250 of its most advanced ventilators from U.S. healthcare providers.
On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of Maquet's facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA just warned practitioners that the company's Flow-i Anesthesia Systems have a problem that "may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately."
Teleflex Medical is in the process of recalling 9,333 units of its Hudson RCI manual ventilator for emergency resuscitation because "the intake port may be blocked which can cause the bag to fail to fill," according to the FDA's recall database.
HeartWare will replace the controllers of all 3,747 of its artificial blood pumps, marking its fifth corrective action of the year deemed a Class 1 recall by the FDA. Class 1 recalls are reserved for situations in which the agency believes there is a reasonable probability that use of or exposure to the device "will cause serious adverse health consequences or death."