Z-0112-2023 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
- 111 boxes (11,100 syringes)
Product Description
Medicina Reusable Oral syringe 1ml Code: OTH01
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)05056115402869 (01)05056115402869(17)260700(10)HM21053 Batch number: HM18041, HM21053