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Abeon Medical Corporation recalls TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a su
Recalled January 27, 2016 · FDA recall Z-0685-2016 · 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
1,035 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 Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Manufacturer(s)
Abeon Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →