Merit Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1144-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 20, 2017

Date Posted: March 28, 2018

Recall Number: Z-1144-2018

Event ID: 79426

Reason for Recall:

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

Status: Terminated

Product Quantity: 44

Code Information:

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

Distribution Pattern:

United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated