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Terminated

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.

FDA Recall Z-0618-2013 · Posted 2012-12-28

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeDWF
Date Initiated2012-11-19
Date Terminated2013-04-04
Product Quantity1552

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.

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113845TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACEMedtronic, Inc. · 2012-01-25K012538TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACEMedtronic Vascular · 2001-08-23K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc. · 1989-05-31K800178EXTRACORP.'S INTERSEPT CUS. TUBING PK.Extracorporeal Medical Specialities, Inc. · 1980-02-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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