Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact an

FDA device recall Z-0618-2013 · posted 2012-12-28 · Terminated

Recall details

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

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.

Action taken

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

Status

Terminated

Product code

DWF

Quantity affected

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.

Date initiated

2012-11-19

Date posted

2012-12-28

Date terminated

2013-04-04

Location

Saint Paul, MN

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