Device product
STERILE STERILE PREP STICK, REF DYNDA1134
Z-0527-2024
Product summary
- Event
- Event 93395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-0527-2024
Official wording
Reason: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Code information: UDI/DI 40888277098023 (case), 10888277098022 (each), Lot numbers: 2023082190
Distribution pattern: US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Derived failure modes
-
Unknown
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.