medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Rec

Recalled Product

Thio Med w/o Ind, w/Dex (10ml) 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: R07176; Lot Number (Labeled Expiration Date): 309154 (12/12/2018), 328732 (01/16/2019), 340307 (02/07/2019), 362767 (03/25/2019), 366061 (03/28/2019), 386121 (05/08/2019), 392563 (05/21/2019), 404767 (06/13/2019). Expansion Lot Number (Labeled Expiration Date): 435420 (08/13/2019). Material Number: R8850; Lot Number (Labeled Expiration Date): 329867 (01/17/2019), 354771 (03/07/2019), 377024 (04/22/2019), 394853 (05/23/2019), 417667 (07/16/2019).

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