Z-0107-2023 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
9 boxes (900 syringes)

Product Description

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

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)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018