INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Check against the official notice below — it lists the full affected range.
Intera Oncology, Inc. is recalling 50 units of its INTERA 3000 Hepatic Artery Infusion Pump due to a hazard involving higher than expected flow rate. The affected pumps were distributed across the United States in Alabama, California, Illinois, Kentucky, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, and Texas. The recalled units can be identified by UDI-DI 00850014110147, Catalogue Number AP03000H, and specific serial numbers ranging from 16145 to 16485.
The recall source does not specify a remedy or recommended action for consumers who may have received one of the affected devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Higher than expected flow rate.
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. Quantity: 50 units 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.