Recall Z-0478-2023 ยท FMF Syringe, Piston
Allison Medical, Inc.
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
| Date | Dec 13, 2022 (initiated Sep 3, 2020) |
| Status | Completed |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/3/20, and later on 3/2/21, recall notices were emailed to customers who were informed to stop using and destroy or return affected devices to the recalling firm. Customers with additional questions could contact the recalling firm at 801-510-8733. |
| Quantity | 2,004 Boxes |
| Distribution | US: IA, LA, MS, FL, PR; OUS: BARBADOS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE U&U Medical Technology Co, Ltd., Feb 27, 2014 |