Z-0478-2023Class II

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Name: Z-0478-2023 CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Creator: Allison Medical, Inc.
Published: 2020-09-03
License: https://open.fda.gov/license/

Allison Medical, Inc. / initiated 2020-09-03 / Completed / root cause: manufacturing process

FDA source

Allison Medical, Inc. began a recall of CarePoint 60 mL Syringe Without Needle, REF: 04-7560 on 2020-09-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0478-2023
Classification: Class II
Status: Completed
Initiated: 2020-09-03
Posted: 2022-12-13
Recalling firm: Allison Medical, Inc.
Product: CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Product code: FMF Syringe, Piston
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 2,004 Boxes
Distribution: US: IA, LA, MS, FL, PR; OUS: BARBADOS
Product codes and lots: UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0478-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2023	Class II	Completed	Voluntary: Firm initiated	2022-12-21	2022-12-13

Product code FMF

K132553Class IIU&u Sterile Piston Syringe without NeedleU&U Medical Technology Co, Ltd. / cleared 2014-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)