Tri-State Centurion Port Access Tray, sterile, 20 per case, Tri-State Hospital Supply Corp., Howell, MI.; Reorder KNV75.
FDA device recall Z-1166-2009 · posted 2009-03-25 · Terminated
Recall details
- Recalling firm
- Tri-State Hospital Supply Corporation
- Reason for recall
- Lack of assurance of sterility, as the package seals may be inadequate.
- Action taken
- Tri-State Hospital Supply Corporation notified all consignees via Urgent Product Recall Notice letter dated January 14, 2009. Consignees were instructed to remove the product from inventory, to inform the firm of amount on hand, and to hold the product for retrieval.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LRS
- Quantity affected
- 340
- Distribution
- Nationwide.
- Date initiated
- 2009-01-14
- Date posted
- 2009-03-25
- Date terminated
- 2009-12-31
- Location
- Howell, MI
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