INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reported: August 31, 2022 Initiated: July 10, 2022 #Z-1522-2022
Product Description
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason for Recall
Higher than expected flow rate.
Details
- Recalling Firm
- Intera Oncology, Inc.
- Units Affected
- 50 units
- Distribution
- US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
- Location
- Wellesley, MA
Frequently Asked Questions
What product was recalled? ▼
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.. Recalled by Intera Oncology, Inc.. Units affected: 50 units.
Why was this product recalled? ▼
Higher than expected flow rate.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Critical. Recall number: Z-1522-2022.
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