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 | Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. |
| Product | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 |
| Quantity | 302 HydroPICC devices |
| Distribution | US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX. |
| Initiated | 2022-12-16 |
| Classified | 2023-02-10 |
| Recall number | Z-1131-2023 |
| 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-1131-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91426/
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