Class 2 Device Recall

• Date Initiated by Firm: June 20, 2003
• Date Posted: July 18, 2003
• Recall Status: Terminated on December 19, 2003
• Recall Number: Z-1027-03
• Recall Event ID: 26586
• Product: Hill-Rom Newborn bassinet; model P247
• Code Information: All units distributed from November 2000 through April 2003.
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; Batesville IN 47006
• For Additional Information Contact: 812-934-7777
• Manufacturer Reason for Recall: The caster/wheel may come off of the bassinet, causing the bassinet to tip.
• FDA Determined Cause: Other
• Action: Customer notification letters dated June 20, 2003 were sent to each customer. Customers are asked to verify the security of the casters to the base and to visually check for loose or missing caster screws, to remove any bassinets from service until repaired, and that Hill-Rom will visit each customer to replace the caster screws on all units.
• Quantity in Commerce: 1,501
• Distribution: United States, Brazil, Canada, China, Italy, Japan, Kuwait Netherlands, Qatar, United Kingdom

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.