Z-1275-2021 Class II Terminated
FDA device recall Z-1275-2021 was initiated by Sirtex Medical Limited on February 22, 2021 and is designated Class II. Reason for recall: There is a potential presence of particulate matter in the D-Vial. The recall status is terminated (terminated April 17, 2023). Affected quantity: 3310.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 22, 2021
- Termination Date
- April 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3310
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Numbers: 1031234, 1031225, 1031227, 1031229