Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
FDA device recall Z-0525-04 · posted 2004-02-10 · Terminated
Recall details
- Recalling firm
- Stryker Medical
- Reason for recall
- A potential shock hazard exists if the night light is damaged.
- Action taken
- Recall letters dated January 21, 2003 were sent to each customer advising them of the firm''s plans to make a product field correction.
- Root cause
- Other
- Status
- Terminated
- Product code
- HDD
- Quantity affected
- 763
- Distribution
- Nationwide, Australia, Brazil, Canada, Chile, Hong Kong, Korea, Kuwait, Latin America, Mexico, Netherlands, Panama, Singapore, Switzerland, United Arab Emirates and United Kingdom.
- Date initiated
- 2004-01-26
- Date posted
- 2004-02-10
- Date terminated
- 2004-06-07
- Location
- Kalamazoo, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADEL 5000 (K950889) | Stryker Corp. | 1995-10-16 |