Recall Z-1565-2021— ICU Medical, Inc.

Name: FDA recall Z-1565-2021
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: K081361. Product: REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.. 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

K081361 — CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXXIcu Medical, Inc.·cleared 2008-08-28

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 CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

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.