Device product
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S 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.
Z-0805-2019
Product summary
- Event
- Event 81942
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2050 units
- Official record key
device-enforcement:Z-0805-2019
Official wording
Reason: There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Code information: Lot Number 3757712
Distribution pattern: US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
Derived failure modes
-
Foreign material or chemical contamination
particulate