FDA (Devices) recall action 98333
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
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.
Medline is recalling certain Dialysis On/Off Kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
Medline is recalling Apheresis Subqport Access Kits and Central Line Insertion kits containing Tego Connectors because the silicone seal may dome or tear, which can occlude the fluid path or allow leakage.
Medline is recalling convenience kits containing Tego Connectors, sold as the Medline Dialysis Dressing Change kit, because the silicone seal may dome or tear and occlude the fluid path.
Medline is recalling seven convenience kits used for dialysis maintenance because the silicone seal on the Tego Connectors may dome or tear, which can occlude the fluid path.
Medline Industries, LP is recalling specific Medline Kits containing Tego Connectors because the silicone seals may dome or tear, potentially causing fluid leakage or blocked paths.
Medline Industries is recalling dialysis dressing change kits containing Tego Connectors due to potential silicone seal doming or tearing that may block fluid flow during use.