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Remel Inc recalls Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general
Recalled May 29, 2019 · FDA recall Z-1377-2019 · Remel
Hazard
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days. · FDA Class II
Units
8,615 units
Sold at
Worldwide Distribution -US Nationwide distribution to AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Singapore
Description
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Product
Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Manufacturer(s)
Remel Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →