The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1555-2018·Announced 2018-05-16

Vyaire Medical Recalls AirLife Pediatric Resuscitation Devices Due to Mask Sticking

Vyaire Medical is recalling 24 AirLife Pediatric 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 24 units of AirLife Resuscitation, Pediatric devices, part number 2K8008F, lot 0001009055. 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 these specific 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 devices were distributed worldwide, including in the United States (nationwide), Canada, Puerto Rico, the United Arab Emirates, the Philippines, and Europe. Consumers and healthcare providers should stop using the affected devices and contact Vyaire Medical for instructions on how to proceed.

The recalled product

Product
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not…
Manufacturer
Vyaire Medical
Category
Medical Device — Resuscitation Equipment
Hazard
Affected units
24

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 (1)

  • Part Number: 2K8008F. Lot: 0001009055

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 →

Related recalls

Same manufacturer · Vyaire Medical

See all →

Same hazard · mechanical defect

See all →

Similar recalls