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
Reported: May 20, 2020 Initiated: January 2, 2020 #Z-1996-2020
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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 20
- Distribution
- 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.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ICU Medical, Inc.. Units affected: 20.
Why was this product recalled? ▼
Inability for the guidewire to pass through the needles included with the catheter kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-1996-2020.
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