HydroFlock Sterile Flocked Collection Device — Class II medical device recall Z-1391-2024
Ongoing recall by Puritan Medical Products Company, Llc, reported 2024-04-03, distributed nationwide. It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed pr
| Recall number | Z-1391-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Puritan Medical Products Company, Llc, Guilford, ME, United States |
| Recall initiated | 2024-02-21 |
| Classified | 2024-03-28 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, TH |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00609576330322 |
| Lot numbers | S1014 |
| Model numbers | 25-3317-H |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1391-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.