medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: R

Recalled Product

Thio Med w/Dex, Hem, Vit K (10ml) 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: R07182; Lot Number (Labeled Expiration Date): 309155 (12/12/2018), 329971 (01/17/2019), 346674 (02/26/2019), 354842 (03/07/2019), 376323 (04/18/2019), 398234 (06/06/2019), 404772 (06/13/2019).
View official government recall

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