Recall Z-0478-2023— Allison Medical, Inc.

Name: FDA recall Z-0478-2023
Creator: U.S. Food and Drug Administration
Published: 2020-09-03

Class II · Completed

Class II FDA medical device recall by Allison Medical, Inc., initiated 2020-09-03. It names one FDA 510(k) clearance: K132553. Product: CarePoint 60 mL Syringe Without Needle, REF: 04-7560. 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..

Recalling firm: Allison Medical, Inc.
Classification: Class II
Status: Completed
Initiated: 2020-09-03
Firm location: Littleton, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K132553 — U&U STERILE PISTON SYRINGE WITHOUT NEEDLEU&U Medical Technology Co, Ltd.·cleared 2014-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.