Recall Z-1589-2021— ICU Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by ICU Medical, Inc., initiated 2021-03-16. FDA's recall record names no specific 510(k) clearance for this event. Product: REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).. Reason: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position..
- Recalling firm
- ICU Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-03-16
- Firm location
- San Clemente, CA, United States
Product description
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reason for recall
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Data sourced from openFDA. This site is unofficial and independent of the FDA.