The Recall Desk

FDA (Devices) recall action 68404

Terumo Cardiovascular Systems Corporation recalled 13 products on 2014-07-30

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products
13
Announced
2014-07-30
Critical
0
Units
244,035

Why these products were recalled

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–13 of 13

  • HighFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo Dual-stage Venous Return Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of venous return cannulae used in heart surgery due to loose fiber particulate found during inspection.

    Product
    Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior ven
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo CPB Catheter Kit Recalled for Loose Fiber Particulate

    Terumo CVS is recalling 125 CPB Catheter Kits because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo Recalls Three-stage Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo Cardiovascular Systems is recalling specific lots of Three-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and infe
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Malleable Venous Return Cannulae Due to Particulate

    Terumo CVS is recalling Sarns Malleable Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superi
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Loose Fiber Particulate

    Terumo CVS is recalling 120 units of Sarns Flexible Aortic Arch Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-07-30

    Terumo Recalls Sarns D4 Aortic Arch Cannulae Due to Particulate

    Terumo CVS is recalling Sarns D4 Aortic Arch Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated fo
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate

    Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indic
    Category
    Distribution
    51 states
  • HighFDA (Devices)··2014-07-30

    Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate

    Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Distribution
    51 states
  • ModerateFDA (Devices)··2014-07-30

    Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.

    Product
    Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and i
    Category
    Distribution
    51 states