Reported Oct 10, 2012 · Terminated
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12…
C.R. Bard, Inc., Urological Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.R. Bard, Inc., Urological Division · 8195 Industrial Blvd Ne · Covington, GA · 30014-1497
Is this the product you have?
- 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.
- Lot codes and dates
Catalog # 165808Lot # NGWA1111
- Amount recalled
- 4,032 units
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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