Custom Procedure Trays, containing various configurations of medical and surgical devices, packed in plastic pouches, la
FDA device recall Z-1398-05 · posted 2005-09-14 · Terminated
Recall details
- Recalling firm
- Avid Medical Inc
- Reason for recall
- Defect in packaging of medical devices may compromise sterility of these products used in medical and surgical procedures.
- Action taken
- The recalling firm notified distributors and end users by letter 09/07/05. The notification advised of product packaging in which seal integrity may have been compomised. The recall letter lists specific lots and item numbers of the custom trays to be returned for replacement or reimbursement. A response form is included in the notification.
- Root cause
- Other
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 4281 kits
- Distribution
- The product was sold to distributors and end user medical facilities nationwide.
- Date initiated
- 2005-09-09
- Date posted
- 2005-09-14
- Date terminated
- 2006-05-08
- Location
- Toano, VA
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