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U.S. Department of Health and Human Services

Class 1 Device Recall Safe Spot Infant Resuscitator

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 Class 1 Recall
Safe Spot Infant Resuscitator
see related information
Date Posted November 01, 2012
Recall Status1 Terminated on June 30, 2013
Recall Number Z-0176-2013
Recall Event ID 63347
Premarket Notification
510(K) Number
K012842 
Product Classification Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
Product Safe Spot Infant Resuscitator, Pro-1900 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 Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657.
Recalling Firm/
Manufacturer
Ventlab Corporation
155 Boyce Dr
Mocksville, North Carolina 27028-4187
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact James A. Cochie
336-753-5000
Manufacturer Reason
for Recall
Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
FDA Determined
Cause 2
DESIGN: 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.
Distribution Nationwide Distribution including IL, OH, NY and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BTM and Original Applicant = VENTLAB CORP.
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