Date Initiated by Firm |
September 20, 2017 |
Create Date |
March 20, 2018 |
Recall Status1 |
Terminated 3 |
Recall Number |
Z-1145-2018 |
Recall Event ID |
79426 |
510(K)Number |
K031351
|
Product Classification |
Single use instrument tray - Product Code OJV
|
Product |
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078 |
Code Information |
Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932 |
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 |
1 Cuff catheters were incorrectly configured and labeled as 2 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 |
8 |
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.
|