Z-1391-2024 Class II Ongoing
FDA device recall Z-1391-2024 was initiated by Puritan Medical Products Company, Llc on February 21, 2024 and is designated Class II. Reason for recall: 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 packag… The recall status is ongoing. Affected quantity: 465 boxes x 500 units per box = 232,500 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2024
- Initiation Date
- February 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 465 boxes x 500 units per box = 232,500 units
Product Description
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Reason for Recall
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.
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.
Code Information
Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;