FDA Medical Device Recalls (openFDA)
Edwards Lifesciences AG: Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)
- Recall number
- Z-1934-2009
- Recalling firm
- Edwards Lifesciences AG
- Product
- Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)
- Status
- Terminated
- Initiated
- 2008-03-14
- Posted
- 2009-08-25
- Terminated
- 2012-07-03
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K885281"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3003081151
- Firm city
- San Cristobal
- Firm state
- not on file
- Firm country
- Dominican Republic
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28