Sirtex Medical Recalls SIROS D-Vial Prep Sets Due to Particulate Matter
Sirtex Medical Limited is recalling SIROS D-Vial Prep Sets because of a potential presence of particulate matter in the D-Vial.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential contamination hazard (particulate matter) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Sirtex Medical Limited is recalling SIROS D-Vial Prep Sets, Product Code SIR-10200, due to a potential presence of particulate matter in the D-Vial. The product is intended for single use.
The recall affects 3,310 units distributed nationwide in the United States. The affected lot numbers are 1031234, 1031225, 1031227, and 1031229.
Consumers and healthcare providers should stop using the affected products and contact Sirtex Medical Limited for further instructions.
The recalled product
- Product
- SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
- Manufacturer
- Sirtex Medical Limited
- Affected units
- 3,310
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 (4)
- Lot Numbers: 1031234
- 1031225
- 1031227
- 1031229
Distribution
Distributed nationwide across the United States.
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