Signature Custom Tubing Pack

• • Terminated Z-0826-2017 FDA Class II ·initiated 16 Nov 2016 ·via K924529, on the same 510(k)

  Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.

• • Terminated Z-1023-2016 FDA Class III ·initiated 4 Feb 2016

  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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Full name

Signature(Tm) Custom Tubing Pack

510(k) Number

K924529 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESK Substantially Equivalent — Kit

• Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface

  Class II

  FDA 510(k) K973760 Active Cleared 18 Feb 1998

• Affinity Blood Pump System

  Class II

  FDA 510(k) K964017 Active Cleared 5 Aug 1997

• Affinity Arterial Blood Filter

  Class II

  FDA 510(k) K952532 Active Cleared 6 Oct 1995

• Avecor Pre-Bypass Filter

  Class II

  FDA 510(k) K940126 Active Cleared 28 Jun 1994

• Affinity Venous Reservior Bag

  Class II

  FDA 510(k) K935717 Active Cleared 10 May 1994

• Affinity Cvr

  Class II

  FDA 510(k) K936003 Active Cleared 20 Jun 1994

See all devices from Avecor Cardiovascular, Inc. →

• What is the primary purpose of the Signature Custom Tubing Pack?

  This device is designed to facilitate the transport of blood during cardiovascular procedures. It functions as a vascular, cardiopulmonary bypass catheter, cannula, and tubing system.

• Who is the manufacturer of this device?

  The Signature Custom Tubing Pack is manufactured by Avecor Cardiovascular, Inc., located in Plymouth, Minnesota.

• What is the regulatory status of this device?

  The device is authorized under FDA 510(k) clearance number K924529. It is classified under regulation number 870.4210.