Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal H
FDA device recall Z-0942-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- The product was shipped prior to being sterilized.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 50 needles
- Distribution
- Florida, Georgia, Minnesota, Oklahoma, Ohio, Missouri and internationally to Malaysia.
- Date initiated
- 2003-06-02
- Date posted
- 2003-06-12
- Date terminated
- 2003-09-08
- Location
- McGaw Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SKINNY,FRANSEEN,WESCOTT NEEDLES (K962907) | Baxter Healthcare Corp | 1996-10-23 |