Intera Oncology, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1522-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.

Product Classification:

Class I

Date Initiated: July 10, 2022
Date Posted: August 31, 2022
Recall Number: Z-1522-2022
Event ID: 90642
Reason for Recall:

Higher than expected flow rate.

Status: Terminated
Product Quantity: 50 units
Code Information:

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.

Distribution Pattern:

US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.

Voluntary or Mandated:

Voluntary: Firm initiated