Z-2156-2018 Class II Terminated
FDA device recall Z-2156-2018 was initiated by Sun Med, LLC on May 24, 2018 and is designated Class II. 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. The recall status is terminated (terminated May 12, 2020). Affected quantity: 361 cases.
Recall Details
- Product Type
- Devices
- Report Date
- June 20, 2018
- Initiation Date
- May 24, 2018
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 361 cases
Product Description
MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP
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 Pattern
IL & OH distributors
Code Information
Lot Numbers: 313323, 313355, 313739, 313031, 313093, 313190 & 313272