Bio-Medicus Percutaneous Cannula & Introducer Set

• • Terminated Z-1929-2008 FDA Unclassified (pre-2012) ·initiated 9 May 2008

  Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

510(k) Number

K884129 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bio Medicus Bio Pump Model Bp-80

  Class II

  FDA 510(k) K852698 Active Cleared 30 Sep 1985

• Bio-Cal 370 Heater/Cooler

  Class II

  FDA 510(k) K894980 Active Cleared 2 Nov 1989

• Urine Cultur Stabilization Transport Tube

  Class I

  FDA 510(k) K920761 Active Cleared 19 Jun 1992

• Cardiopulmonary Cannula Tubing

  Class II

  FDA 510(k) K861096 Active Cleared 21 May 1986

• Bio Pack Model 200

  Class II

  FDA 510(k) K853126 Active Cleared 11 Oct 1985

• Bio-Medicus Cannula Introducer

  Class II

  FDA 510(k) K903410 Active Cleared 31 Oct 1990

See all devices from Bio Medicus, Inc. →