medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage;

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

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

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