FDA Recall
Terminated
14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.
Recall: Z-0327-05
·
Initiated November 12, 2004
Recall
- Recall Number
- Z-0327-05
- 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
14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits.
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
61 kits.