FDA Medical Device Recalls (openFDA)
Allison Medical, Inc.: CarePoint 60 mL Syringe Without Needle, REF: 04-7560
- Recall number
- Z-0478-2023
- Recalling firm
- Allison Medical, Inc.
- Product
- CarePoint 60 mL Syringe Without Needle, REF: 04-7560
- Status
- Completed
- Initiated
- 2020-09-03
- Posted
- 2022-12-13
- Terminated
- not on file
- 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
- Lot, serial or model codes
- UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522
- 510(k) numbers
- ["K132553"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1000138447
- Firm city
- Littleton
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28