Recall Z-1567-2021— ICU Medical, Inc.

Name: FDA recall Z-1567-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-16

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2021-03-16. It names one FDA 510(k) clearance: K082806. Product: REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: 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).. 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

510(k) clearances named in this recall

1 on FDA's record

K082806 — SPINNING SPIROS, MODEL CH-2000Icu Medical, Inc.·cleared 2009-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: 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).

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.