FDAClass IOctober 18, 2023

10ml Syringe Luer Lock W/needle recall: Foreign Material

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Why was 10ml Syringe Luer Lock W/needle recalled?

There is a potential for blood backfill leakage and foreign material.

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: 16945060500125; All Lots

Product
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
124,773 boxes total
Distribution
US Nationwide.
Recall date
October 18, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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