Agency classClass IOur severity:Severe FDA (Devices)·Z-1568-2018·Announced 2018-05-16

Vyaire Medical Recalls AirLife Resuscitation Devices Due to Mask Sticking

Vyaire Medical is recalling AirLife Resuscitation devices because the mask may stick to the elbow, making it difficult 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 specific lots of AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, and PEEP valve devices. These manual resuscitation devices are 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 issue may result in a difficult or unable-to-disconnect condition of the mask from the elbow of the resuscitator.

The affected products are distributed worldwide, including in the United States, Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. The specific part number is 2K8035, and the affected lots are 001022606, 0001034508, and 0001034509. A total of 3,600 units are involved in this recall.

The recalled product

Product: AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP 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…
Manufacturer: Vyaire Medical
Category: Medical Device — Resuscitation Equipment
Hazard: mechanical-failure
device-malfunction

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 (3)

Part Number: 2K8035. Lots: 001022606
0001034508
0001034509

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 →

Same manufacturer · Vyaire Medical

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