FDAFDA · Food and drugs·Recall number Z-1378-2019
Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Published May 29, 2019 · Recall initiated: April 17, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- 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
- Lot
- Lot Number (Expiration Date): 328725 (01/16/2019), 345633 (02/20/2019), 346706 (02/27/2019), 385229 (05/07/2019), 396646 (05/30/2019), 399823 (06/11/2019).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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