FDA-Device2012-09-26Class I
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP 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 of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
Sold states
US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
Affected count
75 cases & 60 Bottles for reps
Manufactured in
330 East Main Street, Pine Level, NC, United States
Products
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2360-2012Don't want to check this manually?
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