FDA recall Z-1344-2018

ICU Medical, Inc. · Class II · device

Product

7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. 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).

Reason for recall

The infusion sets were manufactured with an incorrect spin collar.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-02-05
Report date
2018-04-18
Termination date
2019-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2018