Z-2011-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- May 23, 2012
- Termination Date
- August 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6326
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide)
Code Information
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.