Summary
The FDA issued a Class II for CarePoint 60 mL Syringe Without Needle, REF: 04-7560 by Allison Medical, Inc.. 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 unkn.
Details
Source
Device Recall
External ID
Z-0478-2023
Action Date
2022-12-21
Status
Completed
Category
device
Product Description
CarePoint 60 mL Syringe Without Needle, REF: 04-7560
Lot/Code Info: UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522
Quantity Affected: 2,004 Boxes
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.
Distribution
US: IA, LA, MS, FL, PR; OUS: BARBADOS
Type: Voluntary: Firm initiated
Recall Initiated: 2020-09-03
Company
Littleton, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 474 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Allison Medical, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Allison Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Allison Medical, Inc. have FDA actions?
Allison Medical, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0478-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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