20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 51490).
FDA device recall Z-0336-05 · 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
- 3653 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 GASTROSTOMY KIT (K932861) | Abbott Laboratories | 1994-06-09 |