Device product

Medicina Reusable Oral syringe 5ml Code: OTH05

Z-0113-2023

July 04, 2022

Class II

Product summary

Firm: Medicina Uk Ltd
Event: Event 90849
Status: Ongoing
Classification: Class II
Quantity: 26 boxes (2600 syringes)
Official record key: device-enforcement:Z-0113-2023

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)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055

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