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Intera Oncology, Inc. Recall 90642

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

Intera Oncology, Inc. Recall 90642 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1522-2022
Event ID90642
Event DescriptionINTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Product TypeDevices
DistributionUS distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
Quantity50 units
Recall ReasonHigher than expected flow rate.
Device Classification20220831
Device Code InfoUDI-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.
Center Classification Date20220822
Recall Initiation Date20220710
Recalling FirmIntera Oncology, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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