Terumo Cardiovascular Systems Corp: Medical Device Recalls in 2014

According to to data from the FDA, there were 7 medical device recalls made by Terumo Cardiovascular Systems Corp in 2014. See the details of the recalls below.

You can see similar recalls for other firms.

• 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 Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.
• Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
• 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 is designed to deliver blood/solutions at a 4:1 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
• 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
• 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 activity
• 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.
• 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/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.