CarePoint 60 mL Syringe Without Needle, REF: 04-7560
FDA device recall Z-0478-2023 · posted 2022-12-13 · Completed
Recall details
- Recalling firm
- Allison Medical, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Completed
- Product code
- FMF
- Quantity affected
- 2,004 Boxes
- Distribution
- US: IA, LA, MS, FL, PR; OUS: BARBADOS
- Date initiated
- 2020-09-03
- Date posted
- 2022-12-13
- Location
- Littleton, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| U&U STERILE PISTON SYRINGE WITHOUT NEEDLE (K132553) | U&U Medical Technology Co, Ltd. | 2014-02-27 |