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

Class I - Dangerous
🏥 Medical Devices Recalled: April 17, 2019 Remel Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Remel Inc
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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 Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1400-2019

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