HydroPICC 5Fr Dual Lumen — Class II medical device recall Z-0114-2024
Ongoing recall by Access Vascular, Inc, reported 2023-10-25, distributed nationwide. Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions F
| Recall number | Z-0114-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Access Vascular, Inc, Billerica, MA, United States |
| Recall initiated | 2023-08-31 |
| Classified | 2023-10-13 |
| Reported by FDA | 2023-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 58 total |
| UPC / GTIN / UDI-DI | 00850030354044 |
| Lot numbers | 11423187 |
| Model numbers | 80002002 |
Product
HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Reason for recall
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
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-0114-2024. 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.