Z-0805-2019 Class I Terminated
FDA device recall Z-0805-2019 was initiated by ICU Medical, Inc. on January 3, 2019 and is designated Class I. Reason for recall: There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate The recall status is terminated (terminated May 29, 2024). Affected quantity: 2050 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- January 3, 2019
- Termination Date
- May 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2050 units
Product Description
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.
Reason for Recall
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Distribution Pattern
US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
Code Information
Lot Number 3757712