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U.S. Department of Health and Human Services

Class 2 Device Recall Bipolar Forceps

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 Class 2 Recall
Bipolar Forceps
see related information
Date Posted July 13, 2012
Recall Status1 Open
Recall Number Z-2011-2012
Recall Event ID 62024
Premarket Notification
510(K) Number
K083162 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product 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.
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.
Recalling Firm/
Manufacturer
Stingray Surgical Products, LLC
156 Nw 16th St
Boca Raton, Florida 33432-1607
For Additional Information Contact Brian McBrinn
561-210-7582
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Stingray Surgical Product sent an URGENT Instructions for Use Recall letter dated Mary 23, 2012, to all distributors. The letter identified the product, the problem, and the action to be taken by the client. Distributers were requested to convey the recall to their users along with fowarding copies of the firm's recall notification letter. IFU's will be destroyed or discarded by either user or distributor since returns will not be necessary. Distributors were asked to complete the form at the bottom of the letter and return via e-mail or fax. For questions clients were instructed to call 561-210-7582. For questions regarding this recall call 561-210-7582.
Quantity in Commerce 6326
Distribution Worldwide Distribution - USA (nationwide)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = STINGRAY SURGICAL PRODUCTS, INC
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