Recall Z-1144-2018 ยท OJV Single Use Instrument Tray
Merit Medical Systems, Inc.
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
| Date | Sep 20, 2017 |
| Status | Terminated |
| Reason | 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits. |
| Root cause | 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- |
| Quantity | 44 |
| Distribution | United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031351 | FLEX-NECK PD CATHETER, INFANT Medigroup, Inc., Sep 17, 2003 |