Device product
Medicina Oral Tip Syringe 0.5ml Code: OT005
Z-0109-2023
Product summary
- Firm
- Medicina Uk Ltd
- Event
- Event 90849
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 boxes (12,000 Syringes)
- Official record key
device-enforcement:Z-0109-2023
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)05060278503417 Batch number: HM19024
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