FDA (Devices) recall action 93043
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Access Vascular recalls HydroPICC 5Fr Dual Lumen Maximal Barrier Kits due to incorrect Instructions For Use missing warnings about adult-use only and vessel sizing risks. No adverse events reported.
Access Vascular is recalling HydroPICC Dual Lumen Catheter kits with incorrect instruction documents that omit critical warnings about adult-only use and vessel sizing. No adverse events have been reported.