FDAFDA · Food and drugs·Recall number Z-2331-2012
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Published September 19, 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 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
- Nationwide Distribution including GA, MI, NY, and PA.
- Lot
- 14327-0902, 19929-1006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.