Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufact
FDA device recall Z-1036-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Advance Medical Designs Inc
- Reason for recall
- The product may come apart when excessive force is applied to the coupler.
- Action taken
- Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 2340 units, *amended to include additional 250 units
- Distribution
- Nationwide and Canada
- Date initiated
- 2004-06-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-03
- Location
- Marietta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EQUIPMENT SNAP KOVERS (K850959) | Advance Medical Designs, Inc. | 1985-04-09 |