Z-0107-2023 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
- 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