The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1554-2018·Announced 2018-05-16

Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Mask Sticking

Vyaire Medical is recalling 8,058 pediatric AirLife resuscitation devices because the mask may stick to the elbow, making it difficult or impossible to disconnect.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Vyaire Medical is recalling 8,058 units of AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, and pressure-relief valve. The devices are manual resuscitation tools used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

The recall was initiated because the mask component on various lots has been identified as having the potential to exhibit a sticking condition. This defect may result in a difficult or unable-to-disconnect condition of the mask from the elbow of the resuscitator.

The affected products were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8008, and the affected lots are 00010002841, 0001006156, 0001006158, 0001009054, 0001015412, 0001015413, 0001018698, 0001018699, 0001025674, and 0001030572. Users should check their devices against these lot numbers and contact the manufacturer for instructions.

The recalled product

Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, 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…
Manufacturer
Vyaire Medical
Category
Medical Device — Resuscitation Equipment
Hazard
Affected units
8,058

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • Part Number: 2K8008
  • Lots: 00010002841
  • 0001006156
  • 0001006158
  • 0001009054
  • 0001015412
  • 0001015413
  • 0001018698
  • 0001018699
  • 0001025674
  • 0001030572

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 35 recalled by Vyaire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 35 products in this recall →

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