Recall Z-1391-2024— Puritan Medical Products Company, Llc
Class II · Ongoing
Class II FDA medical device recall by Puritan Medical Products Company, Llc, initiated 2024-02-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Puritan Medical Products Company, Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-21
- Firm location
- Guilford, ME, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.