FDAFDA · Food and drugs·Recall number Z-2011-2012
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.
Published July 25, 2012 · Recall initiated: May 23, 2012
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
On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Stingray Surgical Products, LLC
- Distributor
- Worldwide Distribution - USA (nationwide)
- Lot
- Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps.
- 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.