medical Class I Updated 2018-08-15

Vyaire Medical recalls AirLife Resuscitation Device, Pediatric labeled as the follo

Recalled 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 devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

Hazard / Issue

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

Issued by

FDA

Affected States: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OR, SD, TX, VA, WA
Lot/Code Info: 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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