FDAFDA · Food and drugs·Recall number Z-0010-2013
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.
Published October 10, 2012 · Recall initiated: September 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard, Inc., Urological Division
- Distributor
- Nationwide distribution: USA and Puerto Rico
- Lot
- Catalog # 165808, Lot # NGWA1111
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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