Z-0108-2023 Class II Ongoing

Recalled by Medicina Uk Ltd — Bolton, N/A

Recall Details

Product Type
Devices
Report Date
October 26, 2022
Initiation Date
July 4, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 box (100 syringes)

Product Description

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Reason for Recall

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

Distribution Pattern

Nationwide

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