Merit Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1143-2018)

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:

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

Product Classification:

Class II

Date Initiated: September 20, 2017
Date Posted: March 28, 2018
Recall Number: Z-1143-2018
Event ID: 79426
Reason for Recall:

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

Status: Terminated
Product Quantity: 30
Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated