Recall Z-1243-2009
Edwards Lifesciences, Llc · initiated February 9, 2009
Product
Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.
Codes / lots: Lots: 58612700, 58612702, 58617328, 58617329, 58617330, 58617332, 58617341, 58619706, 58619707, 58619708, 58619709, 58621527, 58621532, 58621535, 58623045, 58623047, 58625221, 58625549, 58627893, 58627899, 58629866, 58630228, 58631725, 58632892, 58633695, 58633696, 58636429, and 58644898.
Reason for recall
Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
FDA-determined cause: Software design
Action taken
Edwards initiated the worldwide recall via Urgent Customer Notification letters dated February 9, 2009 and are being sent by Federal Express starting on February 10, 2009. These letters are requesting that customers cease using Swan-Ganz" Continuous Cardiac Output (CCO) Thermodilution Catheter products from the indicated lots and that they return all unused product. Edwards Lifesciences requested that the customer provide written verification of stock and identify any unused product to be returned. Questions should be directed to Technical Service at 800-822-9837.
Details
- Recall number
- Z-1243-2009
- Initiated
- February 9, 2009
- Posted by FDA
- April 17, 2009
- Terminated
- April 11, 2011
- Product code
- DYG – Catheter, Flow Directed
- Quantity
- 5,756 units
- Distribution
- Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia…
- Recalling firm
- Edwards Lifesciences, Llc, Irvine, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1238-2009 | Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | 02/09/2009Terminated |
| Z-1239-2009 | Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | 02/09/2009Terminated |
| Z-1240-2009 | Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | 02/09/2009Terminated |
| Z-1241-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | 02/09/2009Terminated |
| Z-1242-2009 | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with…Cardiac output measurements were unavailable and the following message is displayed in the Vigilance… | 02/09/2009Terminated |