Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Recall
- Recall Number
- Z-1145-2018
- Event Number
- 79426
- Firm
- Merit Medical Systems, Inc.
- FEI Number
- 1721504
- Product Code
- OJV
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- September 20, 2017
- Address
- 1600 W Merit Pkwy South, Jordan, UT, 84095-2416
Description
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
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 [email protected] 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.
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
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