—#53848

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.

FDA product code: DWE — Tubing, Pump, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K800178, K891687
Affected lot / code info: 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

Why it was recalled

Medtronic Custom Tubing Packs might have open header bag seals.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-08-01
Posted by FDA: 2007-09-25
Terminated: 2008-10-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.