Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
FDA device recall Z-2191-2008 · posted 2008-09-17 · Terminated
Recall details
- Recalling firm
- Cook Vascular Inc.
- Reason for recall
- mislabeled - wrong size catheter was packaged in the box
- Action taken
- The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 20 units
- Distribution
- The products were shipped to distributors in Japan and Brazil.
- Date initiated
- 2008-04-24
- Date posted
- 2008-09-17
- Date terminated
- 2008-09-18
- Location
- Vandergrift, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P (K924748) | Med Institute, Inc. | 1993-07-28 |