Product Safety News

St. Jude sends FDA letter regarding defibrillator leads.

The Wall Street Journal (1/9, Weaver, Subscription Publication, 2.29M) reports St. Jude Medical Inc. sent a letter to Food and Drug Administration in which it admitted there were quality-control mistakes made during the development of its Durata defibrillator leads and provided details as to how it will correct the problems and improve its methods. The letter was in response to a warning letter that the FDA sent to the device manufacturer after agency inspectors conducted an audit at its facility in Little Canada, Minnesota, in October.

CPSC issues warning on Fisher-Price infant sleepers over risk of mold exposure.

The AP (1/9) reports, “The government is warning consumers to inspect Fisher-Price Newborn Rock ‘N Play Sleepers due to risk of exposure to mold for infants who use them.” The article notes that the US Consumer Product Safety Commission “said Tuesday that its warning applies to 800,000 infant recliner seats, called sleepers, that were sold at stores nationwide and online since September 2009, with prices ranging between $50 and $85.” The agency warned that “mold can develop between the removable seat cushion and the hard plastic frame if the sleeper remains wet or is infrequently cleaned.”