—#162330

Product

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

FDA product code: OJV — Single Use Instrument Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K031351
Affected lot / code info: 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

Why it was recalled

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

Timeline

Recall initiated: 2017-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162330. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.