ICU Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1343-2018)

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:

6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, Item A1254, 50 pouches per case, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Product Classification:

Class II

Date Initiated: February 5, 2018

Date Posted: April 18, 2018

Recall Number: Z-1343-2018

Event ID: 79077

Reason for Recall:

The infusion sets were manufactured with an incorrect spin collar.

Status: Terminated

Product Quantity: 550 pouches

Code Information:

Lot number 3533699, UDI (01) 0 0887709 09040 8 (17) 220901 (30) 01 (10) 3533699, and lot number 3549590, UDI (01) 0 0887709 09040 8 (17) 221001 (30) 01 (10) 3549590.

Distribution Pattern:

Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated