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.

Recall Insight

This FDA Devices action (record #Z-0805-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on January 3, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. ICU Medical, Inc. is listed as the recalling firm, operating out of San Clemente, CA. Federal records indicate 2050 units units are affected.

The documented reason for this recall is: There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate Distribution data in the federal record shows the product reached: US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.