FDA-Device2017-07-19Class II
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Hazard
The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Sold states
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Affected count
100 units
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2721-2017More ICU Medical, Inc. recalls
- FDA-Device2026-07-22ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
- FDA-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
- FDA-Device2026-06-17ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
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