FDA Device recall Z-1391-2024
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H by Puritan Medical Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1391-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-21 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Puritan Medical Products |
| Distribution | US |
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.
Identifiers
| code_info | Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2024%22
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