Recall Z-0171-2013 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Ventlab Corporation
Adult Resuscitator, Pro-5000 Series, Single Patient Use, 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.
| Date | Nov 1, 2012 (initiated Jul 11, 2012) |
| Status | Terminated |
| Reason | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. |
| Root cause | Component design/selection |
| 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 CSR@Ventlab.com. For questions regarding this recall call 336-753-5000. |
| Quantity | 14,602 total for all units |
| Distribution | Nationwide Distribution including IL, OH, NY and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012842 | V*CARE MANUAL RESUSCITATOR Ventlab Corp., Sep 18, 2001 |