Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product Codes: REK32N and FEK32HW.
  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:
C.R. Bard, Inc.
Reason for Recall:
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.

Product Codes/Lot Numbers:

Product Codes: REK32N and FEK32HW.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0406-2017

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