FDA recall Z-1096-2019

ICU Medical, Inc. · Class I · device

Product

icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 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.

Distribution

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

Key facts

Status
Terminated
Initiation date
2019-02-21
Report date
2019-04-24
Termination date
2024-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Clemente, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2019