PlainRecalls
FDA Devices Critical Class I Terminated

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. 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 hazar

Reported: April 24, 2019 Initiated: February 21, 2019 #Z-1098-2019

Product Description

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. 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.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
3500 units
Distribution
Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled? ▼
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. 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.. Recalled by ICU Medical, Inc.. Units affected: 3500 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Critical. Recall number: Z-1098-2019.

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