Recall Z-0763-2019
Edwards Lifesciences, LLC · initiated December 21, 2018
Class I – dangerous or defective products that could cause serious health problems or death
Product
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Codes / lots: Lot Numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254
Reason for recall
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
FDA-determined cause: Nonconforming Material/Component
Action taken
An Urgent Product Recall letter was sent via Fed-Ex to affected customers on 12/21/2018. A second communication was sent via Fed-Ex on 01/10/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to the return any unused units that are currently in their inventory. Once returned, replacement product will be shipped at no charge. Customers were asked to complete the attached acknowledgement form. For questions contact Technical Support at 1-800-822-8837 option 1.
Details
- Recall number
- Z-0763-2019
- Initiated
- December 21, 2018
- Posted by FDA
- January 31, 2019
- Terminated
- November 2, 2023
- Product code
- DYG – Catheter, Flow Directed
- Quantity
- 875 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Edwards Lifesciences, LLC, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0762-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | 12/21/2018Terminated |
| Z-0764-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | 12/21/2018Terminated |
| Z-0765-2019 Class I | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The…These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens… | 12/21/2018Terminated |