Z-0478-2023 Class II
FDA device recall Z-0478-2023 was initiated by Allison Medical, Inc. on September 3, 2020 and is designated Class II. Reason for recall: Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown. Affected quantity: 2,004 Boxes.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- September 3, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,004 Boxes
Product Description
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Reason for Recall
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
Distribution Pattern
US: IA, LA, MS, FL, PR; OUS: BARBADOS
Code Information
UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522