Recalls / —

—#162288

Product

Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B

FDA product code

FJS — Catheter, Peritoneal, Long-Term Indwelling

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K031351

Affected lot / code info

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

Why it was recalled

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.

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 #162288. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.