Curium recalls kits for Technetium Tc 99m Sestamibi Injection due to lack of sterility assurance and improper vial crimps. Affected kits may cause infections or product failure. Contact for return instructions.
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Curium is recalling kits used to prepare a radioactive tracer for medical imaging because the vials might not be sterile or could have faulty seals. This could lead to infections or inaccurate test results if used improperly.
The kits may not be sterile, which could cause infections in patients. Improper vial crimps might compromise the product's integrity, leading to inaccurate test results or ineffective treatment.
Healthcare professionals who use these kits for medical imaging procedures are most at risk. Patients receiving the imaging tests may also be affected if the kits are used incorrectly.
Check for the kit's catalog number N092D0, lot number 092-24006, or expiration date of 06/15/2026. These kits were manufactured by Curium US LLC in Maryland Heights, MO.
Verify the catalog number N092D0, lot number 092-24006, or expiration date of 06/15/2026 to confirm if your kit is affected.
The recall addresses potential lack of sterility and improper vial crimps, which could lead to infections or inaccurate test results, but the risk is considered low.
Check for the catalog number N092D0, lot number 092-24006, or expiration date of 06/15/2026 on the kit packaging.
The recall does not specify a remedy, so contact Curium US LLC for further instructions.
We’ve drafted a message you can send Curium to request your refund or repair — edit it as you like.
Subject: Recall D-0164-2025 — Curium Curium Hello, I own a Curium that is covered by recall D-0164-2025 from Curium. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
