FDA-Device2012-07-25Class II
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.
Stingray Surgical Products, LLC
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.
Sold states
Worldwide Distribution - USA (nationwide)
Affected count
6326
Manufactured in
156 Nw 16th St, Boca Raton, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2011-2012Don'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