Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Reported: May 29, 2019 Initiated: April 17, 2019 #Z-1404-2019
Product Description
Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Reason for Recall
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 282 units
- Distribution
- Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes. Recalled by Remel Inc. Units affected: 282 units.
Why was this product recalled? ▼
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1404-2019.
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