Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- February 15, 2023
- Posted
- April 7, 2023
- Recall Number
- Z-1352-2023
- Quantity
- 17 devices
- Firm Location
- Jordan, UT
Reason for Recall
Product that was built for design verification testing was inadvertently distributed to customers.
Distribution
U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Lot / Code Info
Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496
Root Cause
Software Manufacturing/Software Deployment
Action Taken
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.