FDA (Drugs) recall action 78575
The FDA (Drugs) publishes a recall like this one as 68 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 68 pages.
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
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 Industries is recalling IV Start Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling DC Line Kits because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling Suture Removal Packs because the iodine content is below the label claim of 0.85%.
Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling 40 cases of Sheath Removal Kits because the iodine concentration is below the labeled claim.
Medline Industries is recalling sterile staple remover trays containing subpotent povidone-iodine prep pads. The iodine concentration is below the labeled claim of 0.85%.
Medline Industries is recalling sterile staple remover kits because the iodine concentration is below the labeled claim.
Medline Industries is recalling 73 cases of Incision & Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Pacemaker Implant Packs because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.
Medline Industries is recalling IV Start Kits because the iodine concentration in the prep pads is below the labeled claim.
Medline Industries is recalling 600 cases of Laceration Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling Skin Biopsy Packs because the iodine concentration is below the label claim.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the label claim of 0.85%.
Medline is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline is recalling 1,100 cases of GHS Suture Removal Trays because the iodine concentration is below the label claim.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.
Medline Industries is recalling sterile catheter insertion trays because the iodine concentration in the prep pads is below the labeled claim.