Recall Z-0302-05 ยท FMI Needle, Hypodermic, Single Lumen
Boston Scientific Corp
NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
| Date | Dec 9, 2004 (initiated Oct 21, 2004) |
| Status | Terminated |
| Reason | The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles. |
| Root cause | Other |
| Action | Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers. |
| Quantity | 128 kits |
| Distribution | 2 customers in IL and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.