Device product
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Z-1391-2024
Product summary
- Event
- Event 94087
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 465 boxes x 500 units per box = 232,500 units
- Official record key
device-enforcement:Z-1391-2024
Official wording
Reason: It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Code information: Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;
Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IA, ID, IL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, OK, PA, TX, VA and the countries of Canada, P.R. China and Thailand.
Derived failure modes
-
Labeling or packaging
mislabeled