FDA (Devices) recall action 85510
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.
Incorrect Peel-Apart Introducer Sheath in Kit.
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.
Bard Peripheral Vascular Inc is recalling 400 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.
Bard Peripheral Vascular Inc is recalling 215 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.