Z-0109-2023 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
- 120 boxes (12,000 Syringes)
Product Description
Medicina Oral Tip Syringe 0.5ml Code: OT005
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)05060278503417 Batch number: HM19024