FDA-Device2016-01-27Class II
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Abeon Medical Corporation
Hazard
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Sold states
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.
Affected count
1,035 units
Manufactured in
8000 Katherine Blvd, N/A, Brecksville, OH, United States
Products
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0685-2016Don't want to check this manually?
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