Vyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
Vyaire Medical is recalling 15,714 AirLife Adult Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.
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: "An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use."
Plain-English summary
Vyaire Medical is recalling 15,714 units of AirLife Resuscitation Devices, Adult. These are manual resuscitation devices intended for single-patient use to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The recall includes eight specific configurations with part numbers 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8036, 2K8001, 2K8035M, and 2K8004C2.
The recall was initiated due to a manufacturing error that has the potential to obstruct the airflow of supplemental oxygen delivery during use. The affected devices were distributed in the United States to the following states and territories: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PR, SD, TX, VA, and WA.
Healthcare providers and consumers should stop using the affected devices immediately. Users should check their inventory for the specific part numbers and lot numbers listed in the official recall notice. For more information, contact Vyaire Medical or refer to the FDA recall record Z-2552-2018.
The recalled product
- 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…
- Manufacturer
- Vyaire Medical
- Affected units
- 15,714
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 (20)
- 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
Distribution
Part of a larger recall action
This product is one of 2 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.
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