FDAFDA · Food and drugs·Recall number Z-2001-2020
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 # 41414-23
Published May 20, 2020 · Recall initiated: January 2, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inability for the guidewire to pass through the needles included with the catheter kits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.
- Lot
- LOT Number/ UDI - 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, 4365303/1 0840619 04647 4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.