FDA Device recall Z-0618-2013
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurfa…
- FDA Device
- Class II
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class II recall of Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurfa… by Medtronic Cardiac Rhythm Disease Management, citing medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptibl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0618-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-19 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Cardiac Rhythm Disease Management |
| Distribution | US |
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
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.
Identifiers
| code_info | Pack Model Pack Lot 0E27R16- 11239917 11252800 11264666; 1A30R6- 12132577 12219267; 2493R24- 11187015 11199…Pack Model Pack Lot 0E27R16- 11239917 11252800 11264666; 1A30R6- 12132577 12219267; 2493R24- 11187015 11199707 11224309 11227205 11556735; 2493R25- 11646941 11713200 11745242 11813334 11852673 11886412 11990393 12033630 12114699 12178107 12191642 12450856; 5D56R5- 11298229 11357085 11465358 11541270 11601193 11654853 11702415 11745232 11766305 11822320 11838721 11852677 11930380 12024708 12166379 12292156; 5Z93R4- 11713132 11736880 11749958 11766283 11808651 11860604 11878689 11911068 11948473 5Z93R5- 12236493; 12411746 7E64R2- 11933798; 7J53R2- 12172725; 7M13R1- 12168157; 7M14R1- 12349772; 7N16R- 12349786; 7P25R1- 12327801 12449801 12457250; 7P93R1- 12349795 12374420; 7Q11R1- 12344028 12456303; BB7L63R2- 12408737; BB7N26R- 12312571; CB5174R11- 11293051 11315344 11334856 11489271 11745162 11886341 11977682 12019852 12062713 12098852 1213 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0618-2013%22
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