FDA-Device2012-09-26Class I

CMS-5284 Custom Myelogram Tray 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
8 cases
Manufactured in
330 East Main Street, Pine Level, NC, United States
Products
CMS-5284 Custom Myelogram Tray 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-2359-2012

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief