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

Recall Z-1566-2018 — AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their o

U.S. FDA — Device Enforcement · United States · 2017-04-27 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1566-2018
Date of alert
2017-04-27
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Vyaire Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0001010402
Reported risk: The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
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.