FDA (Devices) recall action 95909
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.
Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the 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.
Carwild Corporation is recalling Ivalon Eye Wick 20cm surgical devices due to package seals that are out of specification and cannot guarantee sterile barrier integrity for the life of the product.
Carwild is recalling Ivalon Anatomical Nasal Packing devices because the package seal may be defective, leaving the sterile barrier unable to be guaranteed. Lot 24F1638 with approximately 140 units was distributed across multiple U.S. states and internationally.
Carwild Corporation recalls 300 Ivalon cellulose surgical spears (Model Q604237) due to potential package seal defects that could compromise sterility during ophthalmic surgical procedures.