Ross 18 FR Lap G Laparoscopic Gastrostomy Kit with Brown Mueller T-Fastener Set, Item #51174.
FDA device recall Z-0205-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Ross Products Division, Abbott Laboratories
- Reason for recall
- An increase in reported balloon failures, which may result in tube displacement.
- Action taken
- The firm notified their customers on 11/14/2003 by telephone, fax, and FedEx. Product will be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNT
- Distribution
- Nationwide. Worldwide.
- Date initiated
- 2003-11-14
- Date posted
- 2004-07-20
- Date terminated
- 2008-10-24
- Location
- Columbus, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPLACEMENT GASTROSTOMY TUBE (K861323) | Microvasive | 1986-12-16 |