The Recall Desk

FDA (Devices) recall action 58185

Terumo Cardiovascular Systems Corp recalled 6 products on 2014-11-12

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
2014-11-12
Critical
0
Units
966

Why these products were recalled

Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line

Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.

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.

1–6 of 6

  • HighFDA (Devices)··2014-11-12

    Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect

    Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solu
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    0 states
  • HighFDA (Devices)··2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling 777 Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
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    0 states
  • HighFDA (Devices)··2014-11-12

    Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect

    Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.

    Product
    Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
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    0 states
  • HighFDA (Devices)··2014-11-12

    Terumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect

    Terumo is recalling 165 units of a cardioplegia delivery set line because a luer connector defect can compromise the seal and introduce air into the line.

    Product
    Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activi
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    0 states
  • SevereFDA (Devices)··2014-11-12

    Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect

    Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.

    Product
    Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set i
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    0 states
  • HighFDA (Devices)··2014-11-12

    Terumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect

    Terumo is recalling specific cardiovascular and perfusion procedure kits because a luer connector defect may compromise the seal and introduce air into the table line.

    Product
    Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardiopleg
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    0 states