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Class 2 Device Recall FlexNeck Classic Peritoneal Dialysis Catheter |
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Date Initiated by Firm |
September 20, 2017 |
Create Date |
March 20, 2018 |
Recall Status1 |
Terminated 3 |
Recall Number |
Z-1143-2018 |
Recall Event ID |
79426 |
510(K)Number |
K031351
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Product Classification |
Catheter, peritoneal, long-term indwelling - Product Code FJS
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Product |
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B |
Code Information |
Lot #: a) H1136644, Exp 12/31/2018, UDI (01)00884450305850(17)181231(10)H1136644; b) H1139640, Exp 12/31/18, UDI (01)00884450305850(17)181231(10)H1139640 |
Recalling Firm/ Manufacturer |
Merit Medical Systems, Inc. 1600 W Merit Pkwy South Jordan UT 84095-2416
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For Additional Information Contact |
801-253-1600
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Manufacturer Reason for Recall |
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
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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 |
30 |
Distribution |
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FJS and Original Applicant = MEDIGROUP, INC.
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