FDA-Device2012-10-10Class II
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.
C.R. Bard, Inc., Urological Division
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.
Sold states
Nationwide distribution: USA and Puerto Rico
Affected count
4,032 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2013Don't want to check this manually?
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