Recall Z-1098-2019— ICU Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by ICU Medical, Inc., initiated 2019-02-21, terminated 2024-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.