FDA recall Z-2146-2018

Sun Med, LLC · Class II · device

Product

MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116

Reason for recall

There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.

Distribution

IL & OH distributors

Key facts

Status
Terminated
Initiation date
2018-05-24
Report date
2018-06-20
Termination date
2020-05-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2146-2018