medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recom

Recalled Product

Thio Med w/o Ind, w/Dex (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: R064702; Lot Number (Labeled Expiration Date): 303274 (11/29/2018), 327634 (01/15/2019), 359077 (03/18/2019), 379729 (04/25/2019), 391553 (05/20/2019). Expansion Lot Number (Labeled Expiration Date): 423547 (07/30/2019)

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