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 | The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. |
| Product | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 |
| Quantity | 240 units |
| Distribution | US distribution to States of: FL, TN, TX. |
| Initiated | 2023-03-03 |
| Classified | 2023-05-18 |
| Recall number | Z-1605-2023 |
| 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-1605-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92124/
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