—#161254

Product

Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.

FDA product code: DTN — Reservoir, Blood, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K936003
Affected lot / code info: All lots

Why it was recalled

Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic sent an Urgent Medical Device Recall Letter dated January 16, 2018. Customer Actions: Please review your inventory for product affected by this issue. 1.) Immediately identify and quarantine all unused, non-expired, affected product in your inventory. 2.) Return all unused, affected product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 Option 4, or accessing My Orders and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. 3.) Complete the enclosed Customer Confirmation Certificate and scan and email to RS.CFQFCA@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For further questions, please call (763) 526-2494.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.

Timeline

Recall initiated: 2018-01-16
Terminated: 2020-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.