Facility

ACCESS VASCULAR, INC

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

Key facts

6recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3021570645
Establishment type	Manufacture Medical Device
Location	749 Middlesex Turnpike Billerica, MA, US 01821
Registration status	Active · expires 2026
Parent company	Access Vascular, Inc (owner-operator 10058643)
Brand names	HydroPICC; PICC-252; HydroMID; PICC-251; MID-141; PICC-142

Activity by year

Recalls (6)
Inspections (3)

Devices registered here (2)

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Product code LJS (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5970
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Product code FOZ (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5200

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.

FDA inspections (3)

NAI2025-11-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-10-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-06-05
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Access Vascular, Inc

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ACCESS VASCULAR, INC (FEI 3021570645) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021570645-access-vascular-inc/

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