Recall Z-0159-2015— Terumo Cardiovascular Systems Corp
Class II · Terminated
Class II FDA medical device recall by Terumo Cardiovascular Systems Corp, initiated 2011-03-01, terminated 2014-11-06. FDA's recall record names no specific 510(k) clearance for this event. 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 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.. Reason: 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..
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-03-01
- Terminated
- 2014-11-06
- Firm location
- Ashland, MA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.