PlainRecalls
FDA Devices Critical Class I Terminated

icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the

Reported: April 24, 2019 Initiated: February 21, 2019 #Z-1097-2019

Product Description

icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

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
23800 devices
Distribution
Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled? ▼
icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.. Recalled by ICU Medical, Inc.. Units affected: 23800 devices.
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-1097-2019.

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