Device Recall Bipolar Forceps 의 리콜

Recall

62024

Class 2

Z-2011-2012

2012-05-23

2012-07-13

Terminated

United States

2014-08-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109874

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.

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.