FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
- Recall number
- Z-1352-2023
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
- Status
- Open, Classified
- Initiated
- 2023-02-15
- Posted
- 2023-04-07
- Terminated
- not on file
- Reason
- Product that was built for design verification testing was inadvertently distributed to customers.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- 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 response@merit.com 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.
- Quantity
- 17 devices
- Distribution
- U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
- Lot, serial or model codes
- Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FJS
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28