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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1275-2021 |
Event ID | 87393 |
Event Description | SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use. |
Product Type | Devices |
Distribution | US Nationwide distribution. |
Quantity | 3310 |
Recall Reason | There is a potential presence of particulate matter in the D-Vial. |
Device Classification | 20210324 |
Device Code Info | Lot Numbers: 1031234, 1031225, 1031227, 1031229 |
Center Classification Date | 20210318 |
Recall Initiation Date | 20210222 |
Recalling Firm | Sirtex Medical Limited |
Initial Notification | Letter |
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