FDA Recall
Terminated
20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 51490).
Recall: Z-0336-05
·
Initiated November 12, 2004
Recall
- Recall Number
- Z-0336-05
- Event Number
- 30433
- Firm
- Abbott Laboratories
- FEI Number
- 1527460
- Product Code
- LNO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 12, 2004
- Posted
- December 21, 2004
- Terminated
- February 21, 2007
- Address
- 6550 Singletree Dr, Columbus, OH, 43229-1119
Description
20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 51490).
Reason
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
Action
The recalling firm notified customers by letter, dated 11/12/04.
Distribution
The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico.
Quantity
3653 gastrostomy kits.