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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
Adult Resuscitator, Pro-5000 Series		see related information
Date Posted November 01, 2012
Recall Number Z-0171-2013
Product 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.
Code Information Product List 071012, Product Code: PRO-5009P, Lot #102217.
Recalling Firm/
Manufacturer		 Ventlab Corporation
155 Boyce Dr
Mocksville, North Carolina 27028-4187
For Additional Information Contact James A. Cochie
336-753-5000
Reason for
Recall		 Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
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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