🔍 RecallPedia

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Class I - Dangerous
🏥 Medical Devices Recalled: December 18, 2015 C.R. Bard Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.
  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 error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Product Codes/Lot Numbers:

CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1359-2016

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