Device product

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Z-0108-2023

July 04, 2022

Class II

Product summary

Firm: Medicina Uk Ltd
Event: Event 90849
Status: Ongoing
Classification: Class II
Quantity: 1 box (100 syringes)
Official record key: device-enforcement:Z-0108-2023

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)05060278508153(17)250400(10)HM20055 Batch number: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM19009, HM19018, HM19061, HM19084, HM19132, HM19146, HM20006, HM20032, HM20055, HM20095, HM21037, HM21069, HM22019

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