Recall Z-0711-04 ยท GAA Needle, Aspiration And Injection, Disposable
Enpath Medical, Inc.
AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803
| Date | Jul 20, 2004 (initiated Feb 26, 2004) |
| Status | Terminated |
| Reason | The product is labeled as sterile product but had not been sterilized. |
| Root cause | Other |
| Action | The only direct consignee, to whom the product was shipped, was notified of the recall by telephone and fax on February 26, 2004. The consignee was requested to the return the product and to sub-recall the product from their customers. |
| Quantity | 20 ten-pack kits |
| Distribution | All of the product was shipped to a distributor in New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.