Device product
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Z-1461-2024
Product summary
- Event
- Event 94182
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 250 cases (75,000 pieces)
- Official record key
device-enforcement:Z-1461-2024
Official wording
Reason: Product was mislabeled as a Surgical Cap at its dispenser level.
Code information: Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX.
Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI, MN, MO, MT, SD, TN, TX, and WA. The country of Canada.
Derived failure modes
-
Labeling or packaging
mislabeled