Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Advance Medical Designs, Inc.
- Recall Initiated
- June 18, 2004
- Posted
- July 20, 2004
- Terminated
- September 3, 2004
- Recall Number
- Z-1036-04
- Quantity
- 2340 units, *amended to include additional 250 units
- Firm Location
- Marietta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The product may come apart when excessive force is applied to the coupler.
Distribution
Nationwide and Canada
Lot / Code Info
Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154
Root Cause
Other
Action Taken
Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.
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