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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

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

Agency Publication Date: August 8, 2018
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Affected Products

Product: AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen res

a. Part Number 2K8004, Lot Numbers 0001209844, 0001207350, 0001207351, 0001207352, 0001207353; b. Part Number 2K8035C2, Lot Numbers 0001209833; c. Part Number 2K8017, Lot Numbers 0004003362, 0004003363, 0001209835, 0001209836; d. Part Number 2K8005, Lot Numbers 0001207345, 0001207346, 0001207347, 0001207349, 0001209842, 0001209843; e. Part Number 2K8036, Lot Numbers 0001207354, 0001210191, 0001210192; f. Part Number 2K8001, Lot Numbers 0001209841; g. Part Number 2K8035M, Lot Numbers 001209834; h. Part Number 2K8004C2, Lot Numbers 0001209847;

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Product: 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 with neonatal, infant and pediatric masks, Part Number RE1DK5445D; d. Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve, Part Number 2K8039 Manual resuscitation devi

a. Part Number 2K8018, Lot Number 0001210201; b. Part Number 2K8008 Lot Numbers 0001209831, 0001209837; c. Part Number RE1DK5445D, Lot Numbers 0004002563, 0004003205; d. Part Number 2K8039, Lot Number 0001209839

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80500
Status: Resolved
Manufacturer: Vyaire Medical
Manufactured In: United States
Units Affected: 2 products (15,714 units total)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.