Recall Z-0710-2021— ICU Medical, Inc.

Name: FDA recall Z-0710-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-08-31. It names one FDA 510(k) clearance: K080989. Product: Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260. Reason: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-08-31
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080989 — UNIVERSAL VIAL ACCESS SPIKEIcu Medical, Inc.·cleared 2008-05-02

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

Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260

Reason for recall

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Data sourced from openFDA. This site is unofficial and independent of the FDA.