Thio Med w/o Ind, w/Dex (10ml) 20/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: R08852; Lot Number (Labeled Expiration Date): 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019). Material Number: R07178; Lot Number (Labeled Expiration Date): 311677 (12/18/2018), 347391 (02/28/2019), 366062 (03/28/2019), 390570 (05/16/2019), 396653 (05/30/2019), 417781 (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/o Ind, w/Dex (10ml) 20/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: R08852; Lot Number (Labeled Expiration Date): 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019). Material Number: R07178; Lot Number (Labeled Expiration Date): 311677 (12/18/2018), 347391 (02/28/2019), 366062 (03/28/2019), 390570 (05/16/2019), 396653 (05/30/2019), 417781 (07/17/2019).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1404-2019

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