Recall Z-0618-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Inc. Cardiac Rhythm Disease Management
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
| Date | Dec 28, 2012 (initiated Nov 19, 2012) |
| Status | Terminated |
| 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. |
| Root cause | 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, pleas |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012538 | TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE Medtronic Vascular, Aug 23, 2001 |
| K113845 | TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE Medtronic, Inc., Jan 25, 2012 |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc., Feb 21, 1980 |
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc., May 31, 1989 |