Flex-Neck recallZ-1352-2023 · Merit Medical Systems, Inc. · initiated Feb 15, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product that was built for design verification testing was inadvertently distributed to customers.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
On 02/15/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" via email to customers informing them that, Merit Medical Systems, Inc. is voluntarily conducting a recall of the Flex-Neck Catheter External Repair Kit due to an internal system error that inadvertently allowed an engineering configuration to be released for distribution to customers. Customers are instructed to: 1. Immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within their organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within seven (7) days. All affected product shipped to customers must be accounted for on the CRF. 5. Immediately return all affected lots in their possession to Merit, per the instructions in the attached CRF. If customer have any questions concerning this communication, contact Merit Sales Representative or Merit Customer Service at (801) 208-4381 | Hours: 6 am to 6 pm MST | Mon-Fri.
Recall details
- Recall number
- Z-1352-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 15, 2023
- Posted by the FDA
- Apr 7, 2023
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 17 devices
- Product code
- FJS
- Distribution
- U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Product description
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Code information (models, lots, serial numbers)
Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Flex-Neck® 00884450170069Merit Medical Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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