ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    181011S - Lot # E8PF/G, F5CE 181012S - Lot # E8MB/G, E8MV/G & E8PG/G1 181013S - Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S - Lot # E8PB/G & F5CA 181002S - Lot # E8M7/G, E8MR/G & E8PC/G 181003S - Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1
  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:
NewDeal SA
Reason for Recall:
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S

Product Codes/Lot Numbers:

181011S - Lot # E8PF/G, F5CE 181012S - Lot # E8MB/G, E8MV/G & E8PG/G1 181013S - Lot # E8MC/G, E8MW/G, E8NF/G, E8NF/G1, E8NZ/G, E8PH/G, F538, F5CG & F7G7 181014S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1 181001S - Lot # E8PB/G & F5CA 181002S - Lot # E8M7/G, E8MR/G & E8PC/G 181003S - Lot # E8MS/G, E8NB/G, E8NV/G, F537 & F5CC 181004S - Lot # E8MD/G, E8NG/G, E8P0/G & E8PJ/1

Distribution:

Distributed in: CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2444-2018

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