PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 24, 2021 Initiated: February 22, 2021 #Z-1275-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Sirtex Medical Limited
Units Affected
3310
Distribution
US Nationwide distribution.
Location
North Ryde, New South Wales, N/A

Frequently Asked Questions

What product was recalled?
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.. Recalled by Sirtex Medical Limited. Units affected: 3310.
Why was this product recalled?
There is a potential presence of particulate matter in the D-Vial.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 24, 2021. Severity: Moderate. Recall number: Z-1275-2021.