Class 2 Device Recall

• Date Initiated by Firm: December 19, 2003
• Date Posted: January 08, 2004
• Recall Status: Terminated on September 14, 2004
• Recall Number: Z-0302-04
• Recall Event ID: 27950
• Product Classification: Bed, Pediatric Open Hospital - Product Code FMS
• Product: Hill-Rom Newborn bassinet; model P247.
• Code Information: All units distributed between May 1989 and March 2001.
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; Batesville IN 47006
• For Additional Information Contact: 800-445-3720
• Manufacturer Reason for Recall: The caster/wheel may come off of the bassinet, causing the bassinet to tip.
• FDA Determined Cause: Other
• Action: Recall letters dated December 19, 2003 were sent to each customer. Customers were instructed to verify the security of the casters to the base, and to visually check for loose or missing caster screws until Hill-Rom can visit each facility and perform a fix.
• Distribution: United States, Australia, Canada, China, France, Germany, Honduras, Israel, Japan, Mexico, Panama, Taiwan, Turkey, United Arab Emirates and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.