Class II — Access Vascular, Inc
| Recalling firm | Access Vascular, Inc |
|---|---|
| Registered facility | ACCESS VASCULAR, INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 |
| Quantity | 58 total |
| Distribution | US Nationwide distribution in the states of IL, TX. |
| Initiated | 2023-08-31 |
| Classified | 2023-10-13 |
| Recall number | Z-0114-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Access Vascular, Inc (Z-0114-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93043/
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