FDAFDA · Food and drugs·Recall number Z-2349-2012
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle 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 in place at the manufacturer 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
- 20182-1006
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.