Merit Medical recalls Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A distributed for design verification testing. This product was not intended for customer use.
Product that was built for design verification testing was inadvertently distributed to customers.
Merit Medical is recalling a specific repair kit for catheters because it was mistakenly sent to customers instead of being used for internal testing. This kit should not be used as it was built for design verification, not actual medical use.
This repair kit was designed for internal testing to verify product design, not for actual medical use. Distributing it to customers means it may not meet medical safety standards. Using it could lead to improper catheter repairs.
Healthcare professionals who received this repair kit for catheter repairs are affected. Patients using the kit for medical purposes are at risk of using an unverified product.
Check for the product name 'Flex-Neck Catheter External Repair Kit', catalog number CE-1400/A, and lot number H2586496. This kit was distributed for design verification testing and not intended for customer use.
Verify the catalog number CE-1400/A and lot number H2586496 to confirm if you have the recalled item.
This repair kit was built for design verification testing and was inadvertently distributed to customers instead of being used for internal testing.
No, this product was not intended for customer use and may not meet medical safety standards.
The recall record does not specify a remedy, so contact Merit Medical Systems for guidance.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1352-2023 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1352-2023 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
