AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall Z-0175-2013 · Posted 2012-11-01
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Recalling FirmVentlab Corporation
Recall StatusTerminated
Product CodeBTM
Date Initiated2012-07-11
Date Terminated2013-06-30
Product Quantity14,602 total for all units
Reason for Recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Firm Action
VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to [email protected]. For questions regarding this recall call 336-753-5000.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution including IL, OH, NY and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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