medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Re

Recalled Product

Thio Med w/Dex, Hem, Vit K (9ml) 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 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Material Number: R064722; Lot Number (Labeled Expiration Date): 314201 (12/20/2018), 337680 (02/04/2019), 346705 (02/27/2019), 362709 (03/25/2019), 380471 (04/29/2019), 396517 (05/28/2019).
View official government recall

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