Class 2 Device Recall HillRom

• Date Initiated by Firm: April 24, 2003
• Date Posted: May 29, 2003
• Recall Status: Terminated on September 25, 2003
• Recall Number: Z-0902-03
• Recall Event ID: 25899
• 510(K)Number: K915779
• Product Classification: Table, Obstetric (And Accessories) - Product Code KNC
• Product: Hill-Rom brand Affinity three birthing bed
• Code Information: All units distributed between January 1, 1999 and July 1, 2002.
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; Batesville IN 47006
• For Additional Information Contact: 812-934-7777
• Manufacturer Reason for Recall: Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
• FDA Determined Cause: Other
• Action: Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
• Distribution: United States, Bahamas, Bermuda, Canada, Colombia, Costa Rica, Dominican Republic, Guam, Japan, Mexico, Panama, Saudi Arabia, South Korea, Taiwan and Venezuela
• 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.

• 510(K) Database: 510(K)s with Product Code = KNC and Original Applicant = HILL-ROM, INC.