FDA (Devices) recall action 79426
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
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.
Merit Medical Systems is recalling 8 dialysis kits containing misconfigured infant catheters. The 1-cuff catheters were incorrectly labeled as 2-cuff products.
Merit Medical Systems is recalling 44 custom dialysis kits because they contain 2-cuff catheters incorrectly configured and labeled as 1-cuff products.
Merit Medical Systems is recalling 30 Flex-Neck Classic Peritoneal Dialysis Catheters because 2-cuff devices were incorrectly configured and labeled as 1-cuff products.