Remel Inc: Medical Device Recall in 2019 - (Recall #: Z-1400-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 17, 2019

Date Posted: May 29, 2019

Recall Number: Z-1400-2019

Event ID: 82683

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,395 units

Code Information:

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)

Distribution Pattern:

Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated