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Class 2 Device Recall Adel |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
January 26, 2004 |
Date Posted |
February 10, 2004 |
Recall Status1 |
Terminated 3 on June 07, 2004 |
Recall Number |
Z-0524-04 |
Recall Event ID |
28135 |
510(K)Number |
K950889
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Product Classification |
Table, Obstetrical, Ac-Powered (And Accessories) - Product Code HDD
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Product |
Stryker brand Adel maternity bed, model 4700, with night light. |
Code Information |
All beds manufactured between August 1, 2000 and December 23, 2003. |
Recalling Firm/ Manufacturer |
Stryker Medical 6300 Sprinkle Rd Kalamazoo MI 49001
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For Additional Information Contact |
Renata Sila 800-669-4968 Ext. 6689
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Manufacturer Reason for Recall |
A potential shock hazard exists if the night light is damaged.
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FDA Determined Cause 2 |
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 |
1391 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HDD and Original Applicant = STRYKER CORP.
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