medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Rec

Recalled Product

Thio Med w/o Ind, w/Dex (18ml) 100/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: R08856; Lot Number (Labeled Expiration Date): 314864 (12/24/2018), 343867 (02/14/2019), 367396 (04/02/2019), 387017 (05/09/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019).

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