Reported Jul 24, 2013 · Terminated
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for…
Karl Storz Endoscopy America Inc.
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: Karl Storz Endoscopy America Inc · 15 Wells St · Southbridge, MA · 01550-4503
Is this the product you have?
- 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions.
- Lot codes and dates
- Lots
12471122811227112171121011205111501114010947109431092510920109161090910907108451
- Lots
- Amount recalled
- 40 units
Where it was sold
Why it was recalled
Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be affected.
This product could cause temporary or reversible health problems — stop using it.
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