FDA Recall
Terminated
Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
Recall: Z-2324-2008
·
Initiated December 5, 2007
Recall
- Recall Number
- Z-2324-2008
- Event Number
- 48958
- Firm
- Ventlab Corporation
- FEI Number
- 1314417
- Product Code
- BTC
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 5, 2007
- Posted
- September 20, 2008
- Terminated
- October 15, 2008
- Address
- 155 Boyce Dr, Mocksville, NC, 27028-4187
Description
Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
Reason
During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
Action
Medline Industries, Waukegan, IL was notified by letter titled URGENT - MEDICAL DEVICE RECALL on/about 12/05/2007. They were instructed to check their facility for any of the the affected product in inventory. If found they were advised to destroy and discard. They were to notify Ventlab of the disposition of the bags at their facility. Contact James Cochie at 336-753-5000 if you have questions.
Distribution
IL
Quantity
571, 500 units