Access Vascular, Inc: 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.

Details from the source

Reason for recall: 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. Quantity: 58 total Lot/code info: UDI-DI: 00850030354044; Lot Number: 11423187

UPC codes

00850030354044

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.