Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Ur

FDA device recall Z-1023-2016 · posted 2016-02-26 · Terminated

Recall details

Recalling firm

Medtronic Perfusion Systems

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.

Action taken

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 RS.CFQFCA@Medtronic.com. 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

Status

Terminated

Product code

DWF

Quantity affected

9890 (7773 US, 2117 OUS)

Distribution

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, Canad

Date initiated

2016-02-04

Date posted

2016-02-26

Date terminated

2016-11-07

Location

Brooklyn Park, MN

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