FDA (Devices) recall action 64776
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
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.
Lighthouse For The Blind is recalling First Aid Type IV Belt Type kits because the iodine ampule labels incorrectly imply the entire package is sterile.
Lighthouse For The Blind is recalling 56,133 First Aid Type I Individual Kits because the iodine ampule labels incorrectly imply the entire package is sterile.
Lighthouse For The Blind is recalling 425 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.
Lighthouse For The Blind is recalling 2,815 antiseptic kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.
Lighthouse For The Blind is recalling 1,034 First Aid Kits because the iodine ampule labels incorrectly imply the entire package is sterile, when only the applicator is sterile.
Lighthouse For The Blind is recalling 227 First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.
Lighthouse For The Blind is recalling 635 Type I First Aid Kits because the iodine ampule labeling incorrectly implies the entire package is sterile.
Lighthouse For The Blind is recalling 41,595 First Aid Type III kits because the iodine ampule labels incorrectly imply the entire package is sterile, rather than just the applicator.