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Recall Observatory FDA recall evidence

Device product

Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

Z-1379-2019

April 17, 2019

Class II

Product summary

Firm
Remel Inc
Event
Event 82677
Status
Terminated
Classification
Class II
Quantity
133 units
Official record key
device-enforcement:Z-1379-2019

Official wording

Reason: 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.

Code information: Lot Number (Expiration Date): 303285 (09/27/2018), 309151 (10/10/2018), 353575 (01/02/2019).

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.