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Abeon Medical Corporation recalls TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use
Recalled January 27, 2016 · FDA recall Z-0684-2016 · Abeon Medical
Hazard
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. · FDA Class II
Units
2,570 units
Sold at
Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.
Description
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Product
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Manufacturer(s)
Abeon Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →