Recall Z-2553-2018
Vyaire Medical · initiated May 8, 2018
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: 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
Reason for recall
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
FDA-determined cause: Equipment maintenance
Action taken
Vyaire Medical notified customers on about 05/08/2018 via URGENT RECALL NOTIFICATION letter. Instructions included to conduct 100% physical inventory for any affected devices, destroy any affected devices according to each facility's destruction protocol, notify customers of the recall if affected devices have been further distributed, and complete and return the Customer Response Form. Questions and comments can be directed to Vyaire Medical's Customer Support Team at 1-833-327-3284 (Option #1) or email: customersupport@Vyaire.com Monday-Friday 8:00 am - 5:30 pm CST.
Details
- Recall number
- Z-2553-2018
- Initiated
- May 8, 2018
- Posted by FDA
- August 8, 2018
- Terminated
- July 7, 2020
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Quantity
- 15,714 units total
- Distribution
- US distribution only to: AL, AR, AZ, CA, CA, CO, FL, GA, HI, IA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC,NJ, NY, OH, OR, PR, SD, TX, VA, WA.
- Recalling firm
- Vyaire Medical, Mettawa, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2552-2018 Class I | AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask…An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of… | 05/08/2018Terminated |