Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with
FDA device recall Z-2324-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Ventlab Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTC
- Quantity affected
- 571, 500 units
- Distribution
- IL
- Date initiated
- 2007-12-05
- Date posted
- 2008-09-20
- Date terminated
- 2008-10-15
- Location
- Mocksville, NC
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