| Class 2 Device Recall SwanGanz CCOomboThermodilution Cath. with AMC THROMBOSHIELD (An Antimicrobial Heparing Coating) | |
Date Initiated by Firm | February 09, 2009 |
Date Posted | April 17, 2009 |
Recall Status1 |
Terminated 3 on April 11, 2011 |
Recall Number | Z-1241-2009 |
Recall Event ID |
51492 |
510(K)Number | K924452 |
Product Classification |
Flow Directed Catheter - Product Code DYG
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Product | Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 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: 744HF75
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. |
Code Information |
Lots: 58612694, 58612695, 58615354, 58615358, 58615361, 58618060, 58618061, 58618062, 58626669, 5862672, 58626679, 58626683, 58629859, 58630224, 58630225, 58630226, 58630227, 58635119, 58636668, 58644190, 58646593, 58646595, and 58646597. |
Recalling Firm/ Manufacturer |
Edwards Lifesciences, Llc 1 Edwards Way Irvine CA 92614-5688
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Manufacturer 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 2 | Software design |
Action | 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. |
Quantity in Commerce | 2,091units |
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, Australia, and Singapore. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DYG
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