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U.S. Department of Health and Human Services

Class 2 Device Recall Firstcare Ultra or Adel

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  Class 2 Device Recall Firstcare Ultra or Adel see related information
Date Initiated by Firm January 26, 2004
Date Posted February 10, 2004
Recall Status1 Terminated 3 on June 07, 2004
Recall Number Z-0526-04
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 and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
Code Information All beds manufactured between January 1, 1997 and December 23, 2003.
Recalling Firm/
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 2
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 242
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 and Original Applicant = STRYKER CORP.