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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Dialysis Kit CF4235 Without Gel

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  Class 2 Device Recall Custom Dialysis Kit CF4235 Without Gel see related information
Date Initiated by Firm September 20, 2017
Create Date March 20, 2018
Recall Status1 Terminated 3
Recall Number Z-1144-2018
Recall Event ID 79426
510(K)Number K031351  
Product Classification Single use instrument tray - Product Code OJV
Product Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Code Information Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585
Recalling Firm/
Manufacturer
Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
FDA Determined
Cause 2
Mixed-up of materials/components
Action On 09/20/17, an URGENT PRODUCT RECALL NOTICE was sent to all direct consignees via mail, informing them of a voluntary recall of specific lots of peritoneal dialysis catheters and catheter containing kits. Consignees were advised to immediately do the following: identify and quarantine effected devices; inform personnel to whom the devices were distributed of the field action; fill out and email the customer response form to response@merit.com within 5 days, and return effected devices within ten days using Federal Express account 112952756. Consignee questions were directed to phone: 801-208-4381 or fax: 801-316-4880. Sales representatives were sent an email communication informing them of the recall and instructing them to contact effected customers to help them return Customer Response Forms and product.
Quantity in Commerce 44
Distribution United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OJV and Original Applicant = MEDIGROUP, INC.
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