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

Recall Z-0175-2013 — 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, comm

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-0175-2013
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.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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