Z-1934-2009

Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product...

Name: Z-1934-2009 Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product...
Creator: Edwards Lifesciences AG
Published: 2008-03-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2008-03-14 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences AG began a recall of Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.) on 2008-03-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1934-2009
Status: Terminated
Initiated: 2008-03-14
Posted: 2009-08-25
Terminated: 2012-07-03
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)
Product code: KRA Catheter, Continuous Flush
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Product code KRA

K885281Class IIVamp Venous/arterial Blood Management ProtectionBaxter Healthcare Corp / cleared 1989-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)