medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Reco

Recalled Product

Thio Med w/o Ind, w/Dex (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: R08852; Lot Number (Labeled Expiration Date): 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019). Material Number: R07178; Lot Number (Labeled Expiration Date): 311677 (12/18/2018), 347391 (02/28/2019), 366062 (03/28/2019), 390570 (05/16/2019), 396653 (05/30/2019), 417781 (07/17/2019).

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