Recall Z-0157-2015— 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. It names one FDA 510(k) clearance: K810079. 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 activity. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
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.