Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32… recallZ-1227-2007 · Medtronic Perfusion Systems · initiated Aug 1, 2007
Terminated All recalls posted in September 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic Custom Tubing Packs might have open header bag seals.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1227-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 1, 2007
- Posted by the FDA
- Sep 25, 2007
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 853 packs
- Product code
- DWE
- FDA submissions
- K800178, K891687
- Distribution
- Nationwide.
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Other devices under the same FDA submission
155 devices cleared under K800178, K891687 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA BB9L72R1Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS3 recalls0 reports
- NA BB8M16R3Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls1 report
- NA BB7P48R4Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB7P46R4Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7X82R4Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8L58R3Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8B70R7Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J98R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J97R8Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8D40R3Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA BB8T77R2Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB10W63R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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