Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures com
FDA device recall Z-0777-06 · posted 2006-04-19 · Terminated
Recall details
- Recalling firm
- Medline Industries, Inc.
- Reason for recall
- The product may not be sterile. The pouches were damaged during sterilization.
- Action taken
- The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 21 cases
- Distribution
- Texas
- Date initiated
- 2006-03-30
- Date posted
- 2006-04-19
- Date terminated
- 2006-05-09
- Location
- Waukegan, IL
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