Recall Z-1522-2022 ยท LKK Pump, Infusion, Implanted, Programmable
Intera Oncology, Inc.
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
| Date | Aug 22, 2022 (initiated Jul 10, 2022) |
| Status | Terminated |
| Reason | Higher than expected flow rate. |
| Root cause | Process design |
| 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 a |
| Quantity | 50 units |
| Distribution | US distribution to states of: AL, CA, IL, KY, MN, MO, NC, NJ, NY, OH, OR, PA, & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.