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U.S. Department of Health and Human Services

Class 2 Device Recall VAMP Jr

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  Class 2 Device Recall VAMP Jr see related information
Date Initiated by Firm March 14, 2008
Date Posted August 25, 2009
Recall Status1 Terminated 3 on July 03, 2012
Recall Number Z-1934-2009
Recall Event ID 52802
510(K)Number K885281  
Product Classification Continuous flush catheter. - Product Code KRA
Product Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)
Code Information Lot numbers:Product manufactured between 8/01/06 and 2/29/08; Product Codes: C7217C3A, C7217C6A, PXVJ0441, PXVJ0705, PXVJ0711, PXVJ0819, PXVJ084, PXVJ0926, PXVJ0993, PXVJ356, T005071A, T100802A, T100803A, T391R00A, T430168A, T430169A, T432902A, T440Z01A, T443952B, T450552C, T450553A, T463403A, T470228C, T470411B, VMP306, VMP306PX, VMP406, VMP406PX, VMP426, VMP426PX, VMP448, VMP448PX 
Recalling Firm/
Manufacturer		 Edwards Lifesciences AG
Parque Industrial Itabo
Km. 18.5 Carr. Sanchez
Haina, San Cristobal Dominican Republic
For Additional Information Contact
888-570-4012
Manufacturer Reason
for Recall		 Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.
FDA Determined
Cause 2		 Equipment maintenance
Action Edwards initiated the recall in the U.S. via a Urgent Customer lNotification letter with attached response confirmation fax-back attachment dated March 10, 2008 and was sent by Federal Express on March 12, 2008 requesting that customers cease using all "VAMP Jr" products and that they return all unused product. Customers were instructed to fax-back the confirmation attachment to 800-422-9329 and contact Edwards Customer service at 888-570-4012 to arrange for return of any unused product and obtain information about replacement product. Edwards Lifesciences requested that the customer provide written verification of stock and identify and unused product to be returned. This will enable a 100% effectiveness check for this recall. For product that was shipped to distributors, contact was made directly from Edwards Lifesciences Corporate Office in Irvine, CA. All product that was distributed internationally will be handled regionally. (i.e. US, Canada, Europe/EMEA, Japan, Intercontinental-including Latin America and Asia Pacific)
Quantity in Commerce 61,199 units
Distribution Worldwide Distribution including USA and the countries of Australia, Austria, Belgium, Brazil, Canada, Canaric Island (Spain), China, Columbia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, Turkey, and United Kingdom.
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 = KRA and Original Applicant = BAXTER HEALTHCARE CORP.
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