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Terminated

Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

FDA Recall Z-1023-2016 · Posted 2016-02-26

Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWF
Date Initiated2016-02-04
Date Terminated2016-11-07
Product Quantity9890 (7773 US, 2117 OUS)

Reason for Recall

Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

Firm Action

Medtronic sent an Urgent Medical Device Safety Alert dated February 2016 to all consignees on February 4, 2016. The letter described the problem and the product involved in the recall. Advised consignees to review the Terumo CVS Urgent Safety Alert and follow the instructions in the Recommended Action Section of the Urgent Safety Alert letter. Requested consignees to completed the Customer Confirmation Certificate and Email completed form(s) to [email protected]. If email is not available, fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic representative or Lifeline Technical Support at 877-526-7890. For questions regarding this recall call 763-391-9000.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE, NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI. Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012538TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACEMedtronic Vascular · 2001-08-23K924529SIGNATURE(TM) CUSTOM TUBING PACKAvecor Cardiovascular, Inc. · 1993-06-23K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc. · 1989-05-31

Official Source

View FDA Recall →

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

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