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U.S. Department of Health and Human Services

Class 1 Device Recall AirFlow Resuscitator, Adult Resuscitator

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  Class 1 Device Recall AirFlow Resuscitator, Adult Resuscitator see related information
Date Initiated by Firm July 11, 2012
Date Posting Updated November 01, 2012
Recall Status1 Terminated 3 on June 30, 2013
Recall Number Z-0175-2013
Recall Event ID 63347
510(K)Number K012842  
Product Classification Ventilator, emergency, manual (resuscitator) - Product Code BTM
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. .
Recalling Firm/
Ventlab Corporation
155 Boyce Dr
Mocksville NC 27028-4187
For Additional Information Contact James A. Cochie
Manufacturer Reason
for Recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
FDA Determined
Cause 2
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 in Commerce 14,602 total for all units
Distribution Nationwide Distribution including IL, OH, NY and TN.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTM and Original Applicant = VENTLAB CORP.