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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit

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  Class 2 Device Recall Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit see related information
Date Initiated by Firm May 26, 2021
Create Date June 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-1960-2021
Recall Event ID 87993
510(K)Number K161962  K142749  
Product Classification Transducer, pressure, catheter tip - Product Code DXO
Product Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
Code Information Lot #s: 63470654, 63505217 and 63592430
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Linnette Torres
949-250-6827
Manufacturer Reason
for Recall
There is a potential that the pressure tubing may detach from the blood sampling system
FDA Determined
Cause 2
Under Investigation by firm
Action On May 26, 2021 Edwards Lifesciences issued a "Urgent Medical Device Recall" Notification via FedEx to all affected consignees. In addition to informing consignees about the recalled product, the firm asked consignees to take the following actions: 1. Action to be taken by user: We request that you return all unused product in your inventory with the model and lot numbered reference above. For product that has been used and will be returned, please contact Customer Service at 1-800-424-3278 to request a biokit. Please review your inventory and quarantine any affected product until prepared for return to Edwards Lifesciences. Please follow the instructions included in the enclosed acknowledgement form an return within 5 days of receipt of this notification. 2. Action to be taken by distributor: Please complete the acknowledgement form and return to US.FCA@edwards.com. Please forward this customer communication to any of your customers who have purchased the impacted Edwards VAMP Jr. and TruWave/VAMP Jr. Products and ask them to return the product toe Edwards with the enclosed acknowledgement form. 3. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product and Edwards will communicate directly with your customers to facilitate the recall and acknowledgement process. Please forward your customer list to US.FCA@edwards.com 4. Adverse Event Reporting in the US: - Please contact the FDA's MedWatch Adverse Event reporting program either online, by regular mail, or by fa: Complete and submit the report Online: WWW.fda.gov/medwatch/report.htm - Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 5. Transmission of the Product Recall: This notice need to be passed on to all individuals within your organization who need to be aware of th
Quantity in Commerce 700 units
Distribution US: AZ CA CO CT DC DE FL GA ID IL IN KY LA MA MD ME MI MN MO MS MT NC ND NE NJ PR SD TX UT VA WA WI WV OUS: Canada, United Kingdom, Italy
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXO and Original Applicant = Edwards Lifesciences LLC
510(K)s with Product Code = DXO and Original Applicant = EDWARDS LIFESCIENCES, LLC.
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