FDAClass IIMarch 24, 2021

SIROS D-Vial Prep Set recall: Particulate Matter

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Why was SIROS D-Vial Prep Set recalled?

There is a potential presence of particulate matter in the D-Vial.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 1031234, 1031225, 1031227, 1031229

Product
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Recalling firm
Sirtex Medical Limited
Quantity
3310
Distribution
US Nationwide distribution.
Recall date
March 24, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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