Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1522-2022

July 10, 2022

Class I

Product summary

Firm
Intera Oncology, Inc.
Event
Event 90642
Status
Terminated
Classification
Class I
Quantity
50 units
Official record key
device-enforcement:Z-1522-2022

Official wording

Reason: Higher than expected flow rate.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Higher than expected flow rate.