FDA (Devices) recall action 62132
The FDA (Devices) publishes a recall like this one as 12 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 12 pages.
The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications.
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.
Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.
Custom Medical Specialties is recalling CT biopsy trays containing PVP Prep Solution because the solution lacked microbial testing and did not meet specifications.
Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.
Custom Medical Specialties is recalling CMS-4975 HSG Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet specifications.
Custom Medical Specialties is recalling CMS-5284 Custom Myelogram Trays containing PVP Prep Solution because the solution lacked microbial testing and failed to meet finished goods specifications.
Custom Medical Specialties is recalling CMS-4316 Custom Vein Trays because the included PVP Prep Solution lacked required microbial testing.
Custom Medical Specialties is recalling CMS-4501-R1 Custom HSG Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.
Custom Medical Specialties is recalling Custom Vein Trays containing Povidone Iodine Prep Solution because the product lacked required microbial testing and failed specifications.
Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.
Custom Medical Specialties is recalling Hysteroscopic Sterilization Packs because the included Povidone Iodine Prep Solution lacked required microbial testing.
Custom Medical Specialties is recalling 75 cases of CMS-8162-R1 Fox Chase Specials Packs containing PVP Prep Solution because the product did not meet finished goods specifications and lacked microbial testing.
Custom Medical Specialties is recalling Abington Radiology Drainage Packs containing PVP Prep Solution because the solution lacked microbial testing and did not meet finished goods specifications.