FDA Enforcement
Class II
Ongoing
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Recall: Z-1391-2024
·
Reported April 3, 2024
Enforcement
- Recall Number
- Z-1391-2024
- Event ID
- 94087
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Puritan Medical Products Company, Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 3, 2024
- Initiation Date
- February 21, 2024
- Classification Date
- March 28, 2024
- Address
- 31 School St, N/A, Guilford, ME, 04443-6388, United States
Description
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
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 Info
Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;
Distribution
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.
Quantity
465 boxes x 500 units per box = 232,500 units