Medtronic Intersept Custom Tubing Pack with or without… recallZ-0618-2013 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Nov 19, 2012

Why it was recalled

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 root cause category: Package design/selection

What the company is doing

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.

Recall details

Recall number

Z-0618-2013

Recall class

Class II

Status

Terminated

Initiated by the company

Nov 19, 2012

Posted by the FDA

Dec 28, 2012

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Quantity

1552

Product code

DWF

FDA submissions

K012538, K113845, K800178, K891687

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.

Product description

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.

Other devices under the same FDA submission

155 devices cleared under K012538, K113845, K800178, K891687 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• NA BB9L72R1

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  3 recalls0 reports
• NA BB8M16R3

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls1 report
• NA BB7P48R4

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA BB7P46R4

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA CB7X82R4

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA BB8L58R3

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA BB8B70R7

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA CB7J98R7

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA CB7J97R8

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA BB8D40R3

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA BB8T77R2

  Medtronic, Inc. · TUBING, PUMP, CARDIOPULMONARY BYPASS
  2 recalls0 reports
• NA CB10W63R1

  Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS
  1 recall2 reports