FDA recall Z-1522-2022
Intera Oncology, Inc. · Class I · device
Product
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason for recall
Higher than expected flow rate.
Distribution
US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
Key facts
- Status
- Terminated
- Initiation date
- 2022-07-10
- Report date
- 2022-08-31
- Termination date
- 2023-09-12
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Wellesley, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1522-2022