Reported Jan 9, 2013 · Terminated
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact…
Medtronic Inc. Cardiac Rhythm Disease Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. Cardiac Rhythm Disease Management · 8200 Coral Sea St NE · Saint Paul, MN · 55112-4391
Is this the product you have?
- Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface)
- with the following Model numbers0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer
- Lot codes and dates
45 of 45 products
Products covered by this recall # Product as published 1 Pack Model Pack Lot 0E27R16- 11239917 11252800 11264666 2 1A30R6- 12132577 12219267 3 2493R24- 11187015 11199707 11224309 11227205 11556735 4 2493R25- 11646941 11713200 11745242 11813334 11852673 11886412 11990393 12033630 12114699 12178107 12191642 12450856 5 5D56R5- 11298229 11357085 11465358 11541270 11601193 11654853 11702415 11745232 11766305 11822320 11838721 11852677 11930380 12024708 12166379 12292156 6 5Z93R4- 11713132 11736880 11749958 11766283 11808651 11860604 11878689 11911068 11948473 5Z93R5- 12236493 7 12411746 7E64R2- 11933798 8 7J53R2- 12172725 9 7M13R1- 12168157 10 7M14R1- 12349772 11 7N16R- 12349786 12 7P25R1- 12327801 12449801 12457250 13 7P93R1- 12349795 12374420 14 7Q11R1- 12344028 12456303 15 BB7L63R2- 12408737 16 BB7N26R- 12312571 17 CB5174R11- 11293051 11315344 11334856 11489271 11745162 11886341 11977682 12019852 12062713 12098852 12139621 12146752 12258941 12277502 12326468 12421465 206110946 18 CB5175R13- 11292866 11334859 11432873 11442937 12182778 12411655 19 CB5Q03R6- 11713162 11766245 11787583 11923139 11934952 20 CB5Q03R7- 12114626 - Amount recalled
- 1552
Where it was sold
Why it was recalled
Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
This product could cause temporary or reversible health problems — stop using it.
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