medical Class II Updated 2019-05-29

Remel Inc recalls Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: R

Recalled Product

Thio Med w/Dex, Hem, Vit K (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: R064720; Lot Number (Labeled Expiration Date): 298486 (11/27/2018), 309147 (12/12/2018), 313760 (12/20/2018), 314883 (12/24/2018), 316606 (12/26/2018), 320904 (01/01/2019), 325887 (01/10/2019), 329880 (01/17/2019), 337679 (02/04/2019), 340776 (02/11/2019), 342665 (02/13/2019), 347320 (02/28/2019), 354828 (03/07/2019), 358178 (03/14/2019), 359886 (03/19/2019), 363510 (03/26/2019), 367408 (04/02/2019), 369555 (04/08/2019), 372099 (04/11/2019), 373073 (04/15/2019), 374683 (04/17/2019), 379731 (04/25/2019), 385227 (05/07/2019), 388691 (05/14/2019), 389364 (05/15/2019), 393231 (05/22/2019), 398293 (06/10/2019), 404758 (06/13/2019), 417773 (07/17/2019).
View official government recall

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