Device product
Medicina Oral Tip Syringe 1ml Code: OT01
Z-0110-2023
Product summary
- Firm
- Medicina Uk Ltd
- Event
- Event 90849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 boxes (2900 syringes)
- Official record key
device-enforcement:Z-0110-2023
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)05060278503424 Batch number: HM18147, HM19012, HM19025, HM19088, HM19164, HM20063 HM21015, HM21072
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