Recall Z-2324-2008
Ventlab Corporation · initiated December 5, 2007
Product
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.
Codes / lots: (NC Facility): Part #720057B (3 Liter bags), Lot #63069, 64872, 65226, 66781, 67068, 67068; Part #720058B (2 Liter bags), Lot#63660, 64877, 65225, 68752; Part #720059B (1Liter bags), Lot#63661, 64878, 65227. (China Facility): Part #720057B, Lot #3B0001, 3B0002, 3B0005, 3B0004, 3B0005; Part #720059B, Lot #1B0001, 1B0002, 1B0003; and Part #720058B, Lot #2B0002
Reason for recall
During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2324-2008
- Initiated
- December 5, 2007
- Posted by FDA
- September 20, 2008
- Terminated
- October 15, 2008
- Product code
- BTC – Bag, Reservoir
- Quantity
- 571, 500 units
- Distribution
- IL
- Recalling firm
- Ventlab Corporation, Mocksville, NC