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Access Vascular Recalls
9 recalls on record · November 16, 2022 to October 25, 2023 · Medical Devices
Recalls by year
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 25, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Hazard: 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.
October 25, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Hazard: 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.
May 24, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Hazard: 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.
March 1, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous acces
Hazard: Label with the incorrect component listed on the inner kit Tyvek header bag
March 1, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous acce
Hazard: Product Mislabeled on the outer bag and inner kit Tyvek header bag
February 22, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
Hazard: 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.
February 22, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Hazard: 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.
February 22, 2023Medical DevicesFDA
Access Vascular, Inc recalls HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Hazard: 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.
November 16, 2022Medical DevicesFDA
Access Vascular, Inc. recalls Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Hazard: 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.