Recall Z-0349-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 units. Catalog numbers S1PIC1.9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C.
| Date | Jan 8, 2005 (initiated Nov 24, 2004) |
| Status | Terminated |
| Reason | complaints of vessel erosion when using this product |
| Root cause | Other |
| Action | The recalling firm issued a letter dated 11/23/04 to physicians informing them of the increase in complaints for vessel erosion and one death (at that time). On 12/3/04, the recalling firm issued a press release to alert the medical community of the problem and the need to return the device. The recalling firm issued a recall letter dated 12/7/04, to the Director of Purchasing, informing them of the adverse events associated with the use of the product and the need to return all of their inventory. |
| Quantity | 36340 units |
| Distribution | The products were shipped to through specialty dealers/distributors to medical facilities nationwide. The product is also sold to government accounts and sales representatives. The product is also sold in Taiwan, Brazil, Hong Kong, Africia, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970434 | NEO-PICC Klein-Baker Medical, Inc., Apr 1, 1997 |