Recall Z-0160-2015— 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: K922992. 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/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.. 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 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.
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.