Z-1522-2022 Class I Terminated
FDA device recall Z-1522-2022 was initiated by Intera Oncology, Inc. on July 10, 2022 and is designated Class I. Reason for recall: Higher than expected flow rate. The recall status is terminated (terminated September 12, 2023). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- July 10, 2022
- Termination Date
- September 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason for Recall
Higher than expected flow rate.
Distribution Pattern
US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX.
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.