Z-2553-2018Class I

AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore...

Name: Z-2553-2018 AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore...
Creator: Vyaire Medical
Published: 2018-05-08
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2018-05-08 / Terminated / root cause: manufacturing process

FDA source

Vyaire Medical began a recall of AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b... on 2018-05-08. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2553-2018
Classification: Class I
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-08-08
Terminated: 2020-07-07
Recalling firm: Jaeger Medical GmbH
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.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 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: [email protected] Monday-Friday 8:00 am - 5:30 pm CST.
Quantity in commerce: 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.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2553-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2552-2018	Class I	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-08
Z-2553-2018	Class I	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-08

Product code BTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)