Class 2 Device Recall Firstcare Ultra

• Date Initiated by Firm: January 26, 2004
• Date Posted: February 10, 2004
• Recall Status: Terminated on June 07, 2004
• Recall Number: Z-0525-04
• Recall Event ID: 28135
• 510(K)Number: K950889
• Product Classification: Table, Obstetrical, Ac-Powered (And Accessories) - Product Code HDD
• Product: Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
• Code Information: All beds manufactured between January 1, 1997 and December 23, 2003.
• Recalling Firm/ Manufacturer: Stryker Medical; 6300 Sprinkle Rd; Kalamazoo MI 49001
• For Additional Information Contact: Renata Sila; 800-669-4968 Ext. 6689
• Manufacturer Reason for Recall: A potential shock hazard exists if the night light is damaged.
• FDA Determined Cause: Other
• Action: Recall letters dated January 21, 2003 were sent to each customer advising them of the firm''s plans to make a product field correction.
• Quantity in Commerce: 763
• Distribution: Nationwide, Australia, Brazil, Canada, Chile, Hong Kong, Korea, Kuwait, Latin America, Mexico, Netherlands, Panama, Singapore, Switzerland, 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.

• 510(K) Database: 510(K)s with Product Code = HDD