FDA (Devices) recall action 62875
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.
The firm saw on the FDA web site a recall by the manufacturer 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 PVP Prep Solution kits because the manufacturer did not perform required microbial testing, meaning the product may not meet specifications.
Custom Medical Specialties is recalling CMS-8412-R2 Custom Cysto Packs because the manufacturer did not perform required microbial testing, causing the product to fail finished goods specifications.
Custom Medical Specialties is recalling CMS-2981-R3 Arthrogram Trays because the manufacturer did not perform microbial testing, causing the product to fail finished goods specifications.
Custom Medical Specialties is recalling 16 cases of CMS-2890 Custom Needle Local Trays because the manufacturer lacked microbial testing and the product did not meet finished goods specifications.