18 Gauge thin wall needle as part of a Central Venous Catheter Kit
FDA device recall Z-0543-04 · posted 2004-02-24 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- 18 gauge needles in Central Venous Catheter kits may be partially occluded.
- Action taken
- Consignees were notified by FedEx letter on 12/17/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 93564
- Distribution
- Nationwide including VA facilities in ID and NC. Foreign distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Columbia, Dominican Republic, Egypt, Greece, Ireland, Italy, Japan, Malaysi
- Date initiated
- 2003-12-17
- Date posted
- 2004-02-24
- Date terminated
- 2004-07-27
- Location
- Abbott 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 |
|---|---|---|
| CVP POLYURETHANE CATHETER (K961552) | Abbott Laboratories | 1997-02-10 |