Recall Z-0057-2017— Circulatory Technology Inc
Class III · Terminated
Class III FDA medical device recall by Circulatory Technology Inc, initiated 2016-07-01, terminated 2017-04-14. It names one FDA 510(k) clearance: K981284. Product: The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.. Reason: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm..
- Recalling firm
- Circulatory Technology Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-07-01
- Terminated
- 2017-04-14
- Firm location
- Oyster Bay, NY, 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
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Reason for recall
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.