Medtronic Perfusion Systems Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
Custom packs with catalogue# / lot #: 3608/7626621, CB2E25R7/7760483, CB2E28R/7760491, CB4Q86R/7226272, 9156R2/8105907, 1D41R10/7372026, 1F61R4 / 7038360, 1E04R7 / 7277651, 9156R2 / 8105907, 1X37R / 7760774, 3608 / 7626621, 0X01R7 / 7278478, 2567R41/ 6577695, 1E97R2 / 7828564, 5G01R / 7734883, CB5305R1 / 7346602, CB4Q86R / 7226272, 2T10R1 / 7252235, 1D91R1 / 7843300, 1A45R3 /7584969, 3M16R5 / 7411494, CB2J35R3 / 7352341, CB3R62R / 7668062, 4V60R / 7934463, DLP2X90R /7504957, 3608 /7626621, 3608/ 7626621, 3C86R9/ 7656387, 3608/ 7626621, 3608/ 7626621, HY2K51R14/ 7438662, 2H08R2/ 7668273, 3608/ 7626621, 1A05R15/ 7038597, CB4826R3 / 7843481, 3608/ 7626621, TL4K84R7/ 7900108, CB3K45R6/ 7626276, 9295R2/ 7934447, 2100R3/ 7694869, CB3U51R7 / 7695001, 9156R2/ 8105907, 9182R3/ 7694914, 0M14R12/ 7694762, 2C50R/ 7760791, 3608/ 7626621, 2K98R1/ 7668290, CB0U83R11/ 7721206, 2997R27/ 7438443, 9156R2/ 8105907, TL3E97R5/ 7722225, TL4J32R8/ 7761048, 2Z75R5/ 7960821, CB2E25R7 /7760483, 4W91R/ 7843431, 3608/ 7626621, 9156R2/ 8105907, 1G69R7/ 7760715, 3608/ 7626621, 2T28R1/ 7899872, 9156R2/ 8105907, 1F77R3/ 7722348, 1F77R3/ 7722348, 1F77R3/ 7722348, DLP4X54R/ 7761021, 3608/ 7626621, 3608/ 7626621
Products Sold
Custom packs with catalogue# / lot #: 3608/7626621, CB2E25R7/7760483, CB2E28R/7760491, CB4Q86R/7226272, 9156R2/8105907, 1D41R10/7372026, 1F61R4 / 7038360, 1E04R7 / 7277651, 9156R2 / 8105907, 1X37R / 7760774, 3608 / 7626621, 0X01R7 / 7278478, 2567R41/ 6577695, 1E97R2 / 7828564, 5G01R / 7734883, CB5305R1 / 7346602, CB4Q86R / 7226272, 2T10R1 / 7252235, 1D91R1 / 7843300, 1A45R3 /7584969, 3M16R5 / 7411494, CB2J35R3 / 7352341, CB3R62R / 7668062, 4V60R / 7934463, DLP2X90R /7504957, 3608 /7626621, 3608/ 7626621, 3C86R9/ 7656387, 3608/ 7626621, 3608/ 7626621, HY2K51R14/ 7438662, 2H08R2/ 7668273, 3608/ 7626621, 1A05R15/ 7038597, CB4826R3 / 7843481, 3608/ 7626621, TL4K84R7/ 7900108, CB3K45R6/ 7626276, 9295R2/ 7934447, 2100R3/ 7694869, CB3U51R7 / 7695001, 9156R2/ 8105907, 9182R3/ 7694914, 0M14R12/ 7694762, 2C50R/ 7760791, 3608/ 7626621, 2K98R1/ 7668290, CB0U83R11/ 7721206, 2997R27/ 7438443, 9156R2/ 8105907, TL3E97R5/ 7722225, TL4J32R8/ 7761048, 2Z75R5/ 7960821, CB2E25R7 /7760483, 4W91R/ 7843431, 3608/ 7626621, 9156R2/ 8105907, 1G69R7/ 7760715, 3608/ 7626621, 2T28R1/ 7899872, 9156R2/ 8105907, 1F77R3/ 7722348, 1F77R3/ 7722348, 1F77R3/ 7722348, DLP4X54R/ 7761021, 3608/ 7626621, 3608/ 7626621
Medtronic Perfusion Systems is recalling Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009- due to Medtronic Custom Tubing Packs might have open header bag seals.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Medtronic Custom Tubing Packs might have open header bag seals.
Recommended Action
Per FDA guidance
Certified letters dated 8/1/07 were sent to customers. The letter explains the situation and requests the impacted product to be returned to Medtronic for replacement or credit. The customers are being requested to complete a Recall Certificate acknowledging the receipt of the information.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026