INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
This recall has been terminated (originally issued August 22, 2022).
- Company
- Intera Oncology, Inc.
- Recall Initiated
- July 10, 2022
- Posted
- August 22, 2022
- Terminated
- September 12, 2023
- Recall Number
- Z-1522-2022
- Quantity
- 50 units
- Firm Location
- Wellesley, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 16204, 16211, 16212, 16219, 16220, 16235, 16244, 16247, 16260, 16270, 16273, 16298, 16304, 16309, 16313, 16319, 16338, 16346, 16354, 16376, 16379, 16389, 16393, 16394, 16395,16402, 16403, 16405, 16408, 16409, 16411, 16425, 16426, 16428, 16433, 16434, 16437, 16450, 16459, 16461, 16464, 16485.
Root Cause
Process design
Action Taken
Customers were notified by a combination of letter, call, and/or email of this recall on July 10, 2022. Customers were informed via notification that Intera 3000 Hepatic Artery Infusion Pumps are being recalled due to complaints reporting higher-than-expected flow rates. Customers are asked to secure affected pumps in inventory to ensure they are not implanted and to contact Intera Oncology at 1-800-660-2660 to arrange return of product. Intera requests physicians continue to monitor the pump flow rate per standard refill procedure, and continue to monitor for liver toxicity to adjust dosing as per standard protocols.