Z-0108-2023 Class II Ongoing
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