Device product
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1116
Z-2146-2018
Product summary
- Firm
- Sun Med, LLC
- Event
- Event 80201
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,742 cases
- Official record key
device-enforcement:Z-2146-2018
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: 313298, 313516, 313588, 313589, 313058, 313060, 313125, 313173, 313297, 313714, 313715 & 313774
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.