FDAClass IIJune 12, 2024

Medline Luer Slip Disposable Syringe Without Needle recall

MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020

Why was Medline Luer Slip Disposable Syringe Without Needle recalled?

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX

Product
MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
5,075,234 syringes
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI.
Recall date
June 12, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls