FDA Device recall Z-1522-2022
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump
- FDA Device
- Class I
- terminated
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class I recall of INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump by Intera Oncology, citing higher than expected flow rate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1522-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-07-10 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Intera Oncology |
| Distribution | AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, TX |
Product
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Reason
Higher than expected flow rate.
Identifiers
| code_info | UDI-DI: 00850014110147; Catalogue No. AP03000H; Serial No. 16145, 16151, 16154, 16171, 16177, 16179, 16196, 16201, 1620…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1522-2022%22
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