FDA (Devices) recall action 96703
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.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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.
Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.
Cook Incorporated is recalling Check-Flo Performer Introducer devices (10.0Fr) because affected units may contain an incorrectly sized introducer sheath, which could compromise proper device function.