Product Safety Recalls

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Sirtex Medical Limited Recall 87393

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

Sirtex Medical Limited Recall 87393 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1275-2021
Event ID87393
Event DescriptionSIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity3310
Recall ReasonThere is a potential presence of particulate matter in the D-Vial.
Device Classification20210324
Device Code InfoLot Numbers: 1031234, 1031225, 1031227, 1031229
Center Classification Date20210318
Recall Initiation Date20210222
Recalling FirmSirtex Medical Limited
Initial Notification Letter
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