FDA-Device2012-09-19Class II
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Custom Medical Specialties, Inc.
Hazard
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.
Sold states
Nationwide Distribution including GA, MI, NY, and PA.
Affected count
4 cases
Manufactured in
330 East Main Street, N/A, Pine Level, NC, United States
Products
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2012Don't want to check this manually?
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