Billerica, MA, United States
Access Vascular, Inc recalls
6 recalls recorded since 2018, most recently on 31 August 2023. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)5
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 August 2023
- Reason
- 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 HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
- Distribution
- US Nationwide distribution in the states of IL, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0114-2024, Z-0115-2024
- HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
- HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Ongoing Class II Medical devices
- Recall started
- 3 March 2023
- 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.
- Distribution
- US distribution to States of: FL, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1605-2023
- HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- Product Mislabeled on the outer bag and inner kit Tyvek header bag
- Distribution
- US Nationwide distribution in the states of FL, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1155-2023
- HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- Label with the incorrect component listed on the inner kit Tyvek header bag
- Distribution
- US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1156-2023
- HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
Ongoing Class II Medical devices
- Recall started
- 16 December 2022
- 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.
- Distribution
- US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1130-2023, Z-1129-2023, Z-1131-2023
- HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
- HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
- HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Terminated Class II Medical devices
- Recall started
- 24 February 2021
- Terminated
- 30 May 2024
- 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.
- Distribution
- Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0199-2023
- Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.