Device product
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Z-0107-2023
Product summary
- Firm
- Medicina Uk Ltd
- Event
- Event 90849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 boxes (900 syringes)
- Official record key
device-enforcement:Z-0107-2023
Official wording
Reason: Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Code information: UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification