20 French Ross Over-the-Guidewire Basic Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (Basic) (li
FDA device recall Z-0334-05 · posted 2004-12-21 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
- Action taken
- The recalling firm notified customers by letter, dated 11/12/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNO
- Quantity affected
- 447 gastrostomy kits.
- Distribution
- The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
- Date initiated
- 2004-11-12
- Date posted
- 2004-12-21
- Date terminated
- 2007-02-21
- 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 |
|---|---|---|
| FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT (K915110) | Abbott Laboratories | 1992-04-14 |