Device product
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
Z-2148-2018
Product summary
- Firm
- Sun Med, LLC
- Event
- Event 80201
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 cases
- Official record key
device-enforcement:Z-2148-2018
Official wording
Reason: 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.
Code information: Lot Numbers: 313444 & 313239
Distribution pattern: IL & OH distributors
Derived failure modes
-
Unknown
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.