Device product

Medicina Reusable Oral syringe 1ml Code: OTH01

Z-0112-2023

July 04, 2022

Class II

Product summary

Firm: Medicina Uk Ltd
Event: Event 90849
Status: Ongoing
Classification: Class II
Quantity: 111 boxes (11,100 syringes)
Official record key: device-enforcement:Z-0112-2023

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)05056115402869 (01)05056115402869(17)260700(10)HM21053 Batch number: HM18041, HM21053

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification