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U.S. Department of Health and Human Services

Class 2 Device Recall SwanGanz CCO/Sv02/CEDV/VIP Thermodilution Catheters

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  Class 2 Device Recall SwanGanz CCO/Sv02/CEDV/VIP Thermodilution Catheters see related information
Date Initiated by Firm May 05, 2015
Date Posted June 02, 2015
Recall Status1 Terminated 3 on October 17, 2016
Recall Number Z-1700-2015
Recall Event ID 71169
510(K)Number K940795  
Product Classification Catheter, flow directed - Product Code DYG
Product Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Code Information lot number 59860969.
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Joy Masline
949-250-3819
Manufacturer Reason
for Recall		 The product failed to meet the internal established statistical test requirement for heparin activity.
FDA Determined
Cause 2		 Process control
Action On 05/05/2015 Edwards sent their consignees a letter including the following instructions: Once you have verified your inventory, please complete the attached acknowledgement form (even if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for an RGA prior to returning any unused product and return unused product to the following address: Edwards Lifesciences Return Goods/RGA # XXXXXX 1212 Alton Pkwy., Irvine, CA 92606-4838
Quantity in Commerce 978
Distribution Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DYG and Original Applicant = BAXTER EDWARDS
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