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

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: 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).
  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/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

Product Codes/Lot Numbers:

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).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1401-2019

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