Sirtex SIR-yttrium 90 microspheres recalled for incorrect expiration date
Sirtex Medical Limited is recalling 21 doses of SIR-yttrium 90 microspheres due to an incorrect expiration date. The product is used to treat unresectable metastatic liver tumors.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, typically corresponding to a score of 1 or 2. The specific issue is an incorrect expiration date, which is a documentation/packaging issue.
Plain-English summary
Sirtex Medical Limited is recalling 21 doses of Sirtex SIR-yttrium 90 microspheres (Radionuclide), product code SIR-Y001. This medical device is indicated for the treatment of unresectable metastatic liver tumors. The recall was initiated because the product bears an incorrect expiration date.
The affected units include batches HB024V02 through HB024V14 and batches HB025V02 through HB024V10. The products were distributed nationwide in the United States, including the District of Columbia and the states of Arizona, California, Connecticut, Georgia, Idaho, Illinois, Kentucky, Louisiana, Maryland, Maine, Missouri, Montana, New Jersey, Nevada, Washington, and West Virginia.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Healthcare providers and patients should verify the expiration dates on their inventory and contact Sirtex Medical Limited for further instructions regarding the affected lots.
The recalled product
- Product
- Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.
- Manufacturer
- Sirtex Medical Limited
- Hazard
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch HB024V02 to HB024V14
- Batch HB025V02 to HB024V10
Distribution
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