Device product
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Z-1275-2021
Product summary
- Event
- Event 87393
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3310
- Official record key
device-enforcement:Z-1275-2021
Official wording
Reason: There is a potential presence of particulate matter in the D-Vial.
Code information: Lot Numbers: 1031234, 1031225, 1031227, 1031229
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter