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.
FDA Recall Z-2324-2008 · Posted 2008-09-20
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Recalling FirmVentlab Corporation
Recall StatusTerminated
Product CodeBTC
Date Initiated2007-12-05
Date Terminated2008-10-15
Product Quantity571, 500 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
IL
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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