Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0171-2013

U.S. FDA — Device Enforcement · United States · 2012-07-11 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0171-2013
Date of alert
2012-07-11
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Ventlab Corporation
Product category
device
Product type
Devices
Reported risk: Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.