FDA (Devices) recall action 65698
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions
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.
Atrium Medical is recalling C-QUR Edge Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.
Atrium Medical Corporation is recalling C-QUR V-Patch Mesh units because the coated mesh may adhere to the inner packaging liner when exposed to high humidity.
Atrium Medical Corporation is recalling C-QUR TacShield Mesh units because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.
Atrium Medical Corporation is recalling C-QUR Mesh products because the coated mesh can adhere to the inner packaging liner when exposed to high humidity.