Access Vascular, Inc
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Access Vascular, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-10-25FDA-DeviceClass IIHydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
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.
- 2023-10-25FDA-DeviceClass IIHydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
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.
- 2023-05-24FDA-DeviceClass IIHydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
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.
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