ICU Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1347-2018)

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:

14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, 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-1347-2018

Event ID: 79077

Reason for Recall:

The infusion sets were manufactured with an incorrect spin collar.

Status: Terminated

Product Quantity: 7,600 pouches

Code Information:

Lot number 3422861, UDI (01) 0 0840619 09588 8 (17) 200301 (30) 01 (10) 3422861; lot number 3489493, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3489493; lot number 3498769, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498769; and lot number 3498773, UDI (01) 0 4987892 06975 8 (17) 200701 (30) 01 (10) 3498773.

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