Recall Z-1144-2018— Merit Medical Systems, Inc.

Name: FDA recall Z-1144-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-20

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2017-09-20. It names one FDA 510(k) clearance: K031351. Product: Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079. Reason: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-09-20
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K031351 — FLEX-NECK PD CATHETER, INFANTMedigroup, Inc.·cleared 2003-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.