Medtronic Intersept Custom Tubing Pack with or without coating — Class II medical device recall Z-0618-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-01-09, distributed nationwide. Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtron
| Recall number | Z-0618-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2012-11-19 |
| Classified | 2012-12-28 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2013-04-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MY |
| Quantity | 1,552 |
| Reason classes | sterility |
| Lot numbers | 0E27R16, 11187015, 11199707, 11217931, 11224309, 11227205, 11239917, 11252800, 11260111, 11264666, 11292866, 11293051, 11298229, 11315344, 11334856, 11334859, 11357085, 11432873, 11442937, 11465358, 11489271, 11541270, 11556735, 11559097, 11601193, 11622968, 11646941, 11654853, 11664762, 11687047, 11687063, 11702415, 11712834, 11713132, 11713162, 11713200, 11724030, 11731501, 11736880, 11745162 and 165 more |
| Model numbers | 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB175R13, CB5174R11, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2 and 20 more |
Product
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 numbers: 0E27R16, 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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.