Device 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.
Z-1997-2020
Product summary
- Event
- Event 85361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260 units
- Official record key
device-enforcement:Z-1997-2020
Official wording
Reason: Inability for the guidewire to pass through the needles included with the catheter kits.
Code information: LOT Number/ UDI-4155346/1 0840619 04409 8, 4174851/1 0840619 04409 8, 4192312/1 0840619 04409 8, 4330851/1 0840619 04409 8, 4351191/1 0840619 04409 8
Distribution pattern: 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.
Derived failure modes
-
Unknown
Inability for the guidewire to pass through the needles included with the catheter kits.