medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Reco

Recalled Product

Thio Med w/o Ind, w/Dex (9ml) 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: R064700; Lot Number (Labeled Expiration Date): 298271 (11/26/2018), 314882 (12/24/2018), 316605 (12/26/2018), 318895 (12/31/2018), 323453 (01/08/2019), 326336 (01/14/2019), 327633 (01/15/2019), 328655 (01/16/2019), 329879 (01/17/2019), 332323 (01/23/2019), 335242 (01/29/2019), 337936 (02/05/2019), 339205 (02/06/2019), 345315 (02/19/2019), 346704 (02/27/2019), 353569 (03/06/2019), 359076 (03/18/2019), 360812 (03/20/2019), 363509 (03/26/2019), 369554 (04/08/2019), 371214 (04/10/2019), 373080 (04/15/2019), 377500 (04/23/2019), 380469 (04/29/2019), 381209 (04/30/2019), 388688 (05/14/2019), 392556 (05/21/2019), 396644 (05/30/2019), 398292 (06/10/2019), 408612 (06/24/2019), 417772 (07/17/2019), 420556 (07/24/2019). Expansion Lot Number (Labeled Expiration Date): 423579(07/31/2019)
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