Device product
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Z-2008-2019
Product summary
- Event
- Event 82138
- Status
- Terminated
- Classification
- Class II
- Quantity
- 428,800
- Official record key
device-enforcement:Z-2008-2019
Official wording
Reason: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.
Code information: Lot Number 8307694
Distribution pattern: The products were distributed to the following US states: FL, IL, KS, MA, ND, NH, NY, OH, PA, RI, SC, VA, and WI. The products were distributed to the following foreign countries: Suriname.
Derived failure modes
-
Unknown
The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.