Recall Z-1092-2019— ICU Medical, Inc.

Name: FDA recall Z-1092-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-21

Class I · Terminated

Class I FDA medical device recall by ICU Medical, Inc., initiated 2019-02-21, terminated 2024-06-04. It names one FDA 510(k) clearance: K081361. Product: icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.. Reason: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device..

Recalling firm: ICU Medical, Inc.
Classification: Class I
Status: Terminated
Initiated: 2019-02-21
Terminated: 2024-06-04
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K081361 — CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXXIcu Medical, Inc.·cleared 2008-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

Reason for recall

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

Data sourced from openFDA. This site is unofficial and independent of the FDA.