Access Vascular, Inc recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Mode
Recalled Product
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Hazard / Issue
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.
Issued by
FDA
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