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 | Terminated |
| Reason | Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package. |
| Product | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter |
| Quantity | 79 kits |
| Distribution | Domestic distribution to NC, RI, NJ, and IL. No foreign distribution. |
| Initiated | 2021-02-24 |
| Classified | 2022-11-07 |
| Terminated | 2024-05-30 |
| Recall number | Z-0199-2023 |
| 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-0199-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90981/
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