HydroFlock Sterile Flocked Collection Device recall: Labeling Error
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Why was HydroFlock Sterile Flocked Collection Device recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;
- Product
- HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
- Recalling firm
- Puritan Medical Products Company, Llc
- Quantity
- 465 boxes x 500 units per box = 232,500 units
- 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.
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)