🔍 RecallPedia

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Class I - Dangerous
🏥 Medical Devices Recalled: September 7, 2012 C.R. Bard, Inc., Urological Division Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog # 165808, Lot # NGWA1111
  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., Urological Division
Reason for Recall:
The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Product Codes/Lot Numbers:

Catalog # 165808, Lot # NGWA1111

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0010-2013

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