RegWardenFDA facility compliance records
Company

Access Vascular, Inc

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2021: 1 recalls; 2022: 3 recalls; 2023: 2 recalls2017201820192020120213202222023202420252026
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-08-31
    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 Hy…
  • Class IIOngoing2023-03-03
    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.
  • Class IIOngoing2022-12-22
    Label with the incorrect component listed on the inner kit Tyvek header bag
  • Class IIOngoing2022-12-22
    Product Mislabeled on the outer bag and inner kit Tyvek header bag
  • Class IIOngoing2022-12-16
    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.
  • Class IITerminated2021-02-24
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Access Vascular, Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10058643-access-vascular-inc/

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