Recall Z-1997-2020— ICU Medical, Inc.

Name: FDA recall Z-1997-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-02

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-01-02, terminated 2022-09-14. It names one FDA 510(k) clearance: K091268. Product: Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.. Reason: Inability for the guidewire to pass through the needles included with the catheter kits..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-02
Terminated: 2022-09-14
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.·cleared 2009-09-18

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

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.

Reason for recall

Inability for the guidewire to pass through the needles included with the catheter kits.

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