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

Recall Z-2553-2018 — AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric, Resuscitation kit wi

U.S. FDA — Device Enforcement · United States · 2018-05-08 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2553-2018
Date of alert: 2018-05-08
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Vyaire Medical
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0001210201

Reported risk: An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

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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