Device 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.
Z-1098-2019
Product summary
- Event
- Event 82291
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3500 units
- Official record key
device-enforcement:Z-1098-2019
Official wording
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.
Code information: Lot Numbers: 3872008, 3899761
Distribution pattern: Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Derived failure modes
-
Foreign material or chemical contamination
particulate