FDAClass IINovember 20, 2024

Irrigation Tubing for KARL STORZ Endomat Select UP210 recall: Labeling Error

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Why was Irrigation Tubing for KARL STORZ Endomat Select UP210 recalled?

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

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?

Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

Product
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Recalling firm
Karl Storz Endoscopy
Quantity
40 units
Distribution
U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
Recall date
November 20, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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