The Medical Device Business Journal — Medical Device News & Articles | MassDevice
The Food & Drug Administration issued its final order for the U.S. recall of Baxter International Inc.’s (NYSE:BAX) Colleague infusion pumps.
The federal watchdog is requiring the Deerfield, Ill.-based company to provide transition guide for hospitals and clinics using Colleague infusion pumps.
The guide will include a list of FDA-cleared or approved pump alternatives and information on refund, replacement and lease termination programs, the regulatory agency said.
Medtronic Inc.’s (NYSE:MDT) headache over its Physio-Control Inc. subsidiary is turning into a veritable migraine, as it reveals another issue with its LifePak line of defibrillators.
Redmond, Wash.-based Physio-Control said it issued a "field correction" for some of its LifePak 20/20e defibrillators, after discovering that some of the devices might lose battery power while in operation.
The Food & Drug Administration plans to launch a public database of recall data this fall, another element in the agency’s quest to become more transparent.
The data, on recalls of medical devices, food products and drugs, will be compiled in a searchable, online database. The data will also be made available in a downloadable XML format.
U.S. regulators are requiring Baxter Healthcare Corp. (NYSE:BAX) to pull all of its Colleague infusion pumps from the market, accusing the medical device manufacturer of a “long-standing” failure to correct problems with the pumps.
As part of its enforcement action, the Food & Drug Administration ordered the Deerfield, Ill.-based company to provide refunds to customers or to replace the pumps at no cost. Both the agency and the company estimate there are about 200,000 of the pumps currently in use.
