Recall Z-1522-2022— Intera Oncology, Inc.
Class I · Terminated
Class I FDA medical device recall by Intera Oncology, Inc., initiated 2022-07-10, terminated 2023-09-12. FDA's recall record names no specific 510(k) clearance for this event. Product: INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.. Reason: Higher than expected flow rate..
- Recalling firm
- Intera Oncology, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-07-10
- Terminated
- 2023-09-12
- Firm location
- Wellesley, MA, United States
Product description
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason for recall
Higher than expected flow rate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.