Recall Z-0942-03 ยท KNW Instrument, Biopsy
Cardinal Health
Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic
| Date | Jun 12, 2003 (initiated Jun 2, 2003) |
| Status | Terminated |
| Reason | The product was shipped prior to being sterilized. |
| Root cause | Other |
| Action | Recalled by telephone call and follow-up letter on 6/2/03. The accounts were informed that the biopsy needles were not sterile, and were requested to examine their inventory for the affected lot and return any found for credit and replacement. |
| Quantity | 50 needles |
| Distribution | Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962907 | SKINNY,FRANSEEN,WESCOTT NEEDLES Baxter Healthcare Corp, Oct 23, 1996 |