| | Class 1 Recall
AirFlow Resuscitator, Adult Resuscitator |  |
| Date Posted |
November 01, 2012 |
| Recall Number |
Z-0175-2013 |
| Product |
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. |
| Code Information |
Product List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151; AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165; AF1140MB-P5, Lot #102145; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666.
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Recalling Firm/
Manufacturer |
Ventlab Corporation
155 Boyce Dr
Mocksville, North Carolina 27028-4187 |
| For Additional Information Contact |
James A. Cochie
336-753-5000
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Reason for
Recall |
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
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| 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. |
| Distribution |
Nationwide Distribution including IL, OH, NY and TN. |
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