Recall Z-1996-2020— ICU Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by ICU Medical, Inc., initiated 2020-01-02, terminated 2022-09-14. FDA's recall record names no specific 510(k) clearance for this event. 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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4. 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
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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
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.