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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

Product Description Breath Tech, Safe Spot Infant Resuscitator, BT2000 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.
Recall Number Z-0174-2013
Classification Class I
Code Info Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081.
Product Distributed Qty 14,602 total for all units
Reason For Recall Possible volume leakage through the inlet valve during compressions of the resuscitator bag.

Event Detail

Event Id 63347
Product Type Devices
Status Ongoing
Recalling Firm Ventlab Corporation
City Mocksville
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including IL, OH, NY and TN.