Recall Z-2324-2008 ยท BTC Bag, Reservoir
Ventlab Corporation
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.
| Date | Sep 20, 2008 (initiated Dec 5, 2007) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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. |
| Quantity | 571, 500 units |
| Distribution | IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.