FDA Device recall Z-1092-2019

icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets

• FDA Device
• Class I
• terminated
• Published 2019-04-24

On 2019-04-24 the FDA classified a Class I recall of icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets by Icu Medical, citing 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 devi….

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1092-2019%22

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