FDA-Device2018-06-20Class II

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

Sun Med, LLC
Hazard

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.

Sold states
IL & OH distributors
Affected count
1,742 cases
Manufactured in
2710 Northridge Dr NW Ste A, N/A, Grand Rapids, MI, United States
Products
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116

Official notice

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

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