medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage:

Recalled Product

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

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): 328725 (01/16/2019), 345633 (02/20/2019), 346706 (02/27/2019), 385229 (05/07/2019), 396646 (05/30/2019), 399823 (06/11/2019).
View official government recall

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