Reported Apr 3, 2024 · Ongoing
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Puritan Medical Products Company, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Puritan Medical Products Company, Llc · 31 School St · Guilford, ME · 04443-6388
Is this the product you have?
- HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
- Lot codes and dates
- Part number25-3317-H
- UDI/DI00609576330322
- Serial/Lot NumberS1014
- Amount recalled
- 465 boxes x 500 units per box = 232,500 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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