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Applied Medical Technology Inc recalls TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indic
Recalled May 11, 2016 · FDA recall Z-1609-2016 · Applied Medical Technology
Hazard
The firm received a complaint of an open pouch which breaches the sterilization validation. · FDA Class II
Units
3,754 Units
Sold at
Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.
Description
The firm received a complaint of an open pouch which breaches the sterilization validation.
Product
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Manufacturer(s)
Applied Medical Technology Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →