Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc Recalled by C.R. Bard, Inc., Urological Division Due to The 8 Fr. Bardex All-Silicone Foley Catheter with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact C.R. Bard, Inc., Urological Division directly.
Affected Products
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.
Quantity: 4,032 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About C.R. Bard, Inc., Urological Division
C.R. Bard, Inc., Urological Division has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report