FDAClass IIApril 19, 2023

Flex-Neck Catheter External Repair Kit recall

Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

Why was Flex-Neck Catheter External Repair Kit recalled?

Product that was built for design verification testing was inadvertently distributed to customers.

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?

Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496

Product
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Recalling firm
Merit Medical Systems, Inc.
Quantity
17 devices
Distribution
U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Recall date
April 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls