Z-1352-2023Class II

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

Name: Z-1352-2023 Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Creator: Merit Medical Systems, Inc.
Published: 2023-02-15
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2023-02-15 / Open, Classified / root cause: software

FDA source

Merit Medical Systems, Inc. began a recall of Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A on 2023-02-15. FDA classified it as Class II and gives the reason as "Product that was built for design verification testing was inadvertently distributed to customers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1352-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-15
Posted: 2023-04-07
Recalling firm: Merit Medical Systems, Inc.
Product: Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Product code: FJS Catheter, Peritoneal, Long-Term Indwelling
Reason for recall: Product that was built for design verification testing was inadvertently distributed to customers.
Root cause tag: software
FDA 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 [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.
Quantity in commerce: 17 devices
Distribution: U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Product codes and lots: Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1352-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1352-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-07

Product code FJS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)