The Recall Desk

FDA (Devices) recall action 64007

Terumo Cardiovascular Systems Corporation recalled 6 products on 2013-01-23

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2013-01-23
Critical
0
Units
40,980

Why these products were recalled

Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

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

1–6 of 6

  • HighFDA (Devices)··2013-01-23

    Terumo Recalls Sarns Arterial Cannulas Due to Connector Flash

    Terumo is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because connector flash may detach during surgery.

    Product
    Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Ca
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2013-01-23

    Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns high-flow aortic arch cannulas because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2013-01-23

    Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns High-Flow Aortic Arch Cannulas and Flexible Arterial Cannulae because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are i
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2013-01-23

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Connector Flash

    Terumo Cardiovascular Systems is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because the connectors contain flash that may detach during surgery.

    Product
    Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cann
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2013-01-23

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns high-flow aortic arch and flexible arterial cannulas because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible
    Category
    Distribution
    32 states
  • HighFDA (Devices)··2013-01-23

    Terumo Sarns Arterial Cannulas Recalled for Connector Flash Defect

    Terumo is recalling Sarns flexible arterial and high-flow aortic arch cannulas because exterior flash on the connectors may detach during surgery.

    Product
    Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannula
    Category
    Distribution
    32 states