Z-0114-2023 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
- 20 boxes (2000 syringes)
Product Description
Medicina Reusable Oral syringe 2.5ml Code: OTH25
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)05056115402876 Batch number: HM18042, HM21019, HM21054