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Terminated

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

FDA Recall Z-1522-2022 · Posted 2022-08-22

Recalling FirmIntera Oncology, Inc.
Recall StatusTerminated
Product CodeLKK
Date Initiated2022-07-10
Date Terminated2023-09-12
Product Quantity50 units

Reason for Recall

Higher than expected flow rate.

Firm Action

Customers were notified by a combination of letter, call, and/or email of this recall on July 10, 2022. Customers were informed via notification that Intera 3000 Hepatic Artery Infusion Pumps are being recalled due to complaints reporting higher-than-expected flow rates. Customers are asked to secure affected pumps in inventory to ensure they are not implanted and to contact Intera Oncology at 1-800-660-2660 to arrange return of product. Intera requests physicians continue to monitor the pump flow rate per standard refill procedure, and continue to monitor for liver toxicity to adjust dosing as per standard protocols.

Root Cause

Process design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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