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U.S. Department of Health and Human Services

Class 2 Device Recall FlexNeck Catheter External Repair Kit

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  Class 2 Device Recall FlexNeck Catheter External Repair Kit see related information
Date Initiated by Firm February 15, 2023
Date Posted April 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-1352-2023
Recall Event ID 91852
Product Classification Catheter, peritoneal, long-term indwelling - Product Code FJS
Product Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Code Information Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact Customer Service
801-208-4381
Manufacturer Reason
for Recall		 Product that was built for design verification testing was inadvertently distributed to customers.
FDA Determined
Cause 2		 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 in Commerce 17 devices
Distribution U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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