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.
Reported: March 6, 2019 Initiated: January 3, 2019 #Z-0805-2019
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
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 2050 units
- Distribution
- US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ICU Medical, Inc.. Units affected: 2050 units.
Why was this product recalled? ▼
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2019. Severity: Critical. Recall number: Z-0805-2019.
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