FDAFDA · Food and drugs·Recall number Z-2350-2012
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Published September 26, 2012 · Recall initiated: September 30, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Custom Medical Specialties, Inc.
- Distributor
- US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
- Lot
- 15011-0904 and 16363-0908
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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