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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Intersept Tubing Packs

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  Class 2 Device Recall Medtronic Intersept Tubing Packs see related information
Date Initiated by Firm November 19, 2012
Date Posted December 28, 2012
Recall Status1 Terminated 3 on April 04, 2013
Recall Number Z-0618-2013
Recall Event ID 63769
510(K)Number K800178  K891687  K012538  K113845  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
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.

Code Information 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  12139621  12146752  12258941  12277502  12326468  12421465  206110946;  CB5175R13- 11292866  11334859  11432873  11442937  12182778  12411655;  CB5Q03R6- 11713162  11766245  11787583  11923139  11934952;  CB5Q03R7- 12114626; CB6C53R6- 12423767; CB7C15R2- 12411647; CB7C59R2- 11731501;  11813316  11838743  11869767  11908794  11982413  12019907  12146796  12151706  12201727  12292133  12423702; CB7C60R2- 11687047  11724030  11843434  11878672; CB7C74R2- 11895167; CB7D91R5- 11961280  12130493  12146882  12191604  12277455  12411687  12423760;  CB7E35R2- 11839101;  CB7E38R1- 11843886  11885844  11990360  12105025  12133083  12159400;  CB7G21R4- 12032413  12033728  12040524  12083359  12360622;  CB7L48R1- 12301694; CB7L72R1- 12155258; CB7P82R1- 12440601; HY6U96R2- 206133995; HY6Y52R2- 11826276; HY7E87R1- 11830948  11898103  11923498  12323794  12435409; SS7J91R3- 12175428; SSCB7L48R- 12120109; SSTL7G78R1 -11986264; TL5S33R7- 12093478;  12139612  12172589  12315375;  TL6V77R1- 11217931  11260111;  TL7B51R1- 11559097  11622968  11664762  11687063  11712834;  TL7G20R3- 12258680  12271138  12360554 TL7G78R3- 12067309; TL7R87R1- 206114578  206145379 
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact
763-526-6000
Manufacturer 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.
FDA Determined
Cause 2		 Package design/selection
Action Medtronic sent a "Urgent Medical Device Customer Notification" letter dated November 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected product and to return affected product, but if they have concerns about replacement than they recommend to inspect and return any damaged product.. For further questions please contact your local Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. Outside the US, please call 1+763-526-7890. We apologize for any inconveniences this issue may have caused you or your institution.
Quantity in Commerce 1552
Distribution Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC BLOOD SYSTEMS, INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC VASCULAR
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