Device product
Medicina Oral Tip Syringe 2.5ml Code: OT25
Z-0111-2023
Product summary
- Firm
- Medicina Uk Ltd
- Event
- Event 90849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 boxes (2000 syringes)
- Official record key
device-enforcement:Z-0111-2023
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)05060278503431 Batch number: HM19026, HM19165, HM20019, HM20064, HM21061
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