Karl Storz Balloon Catheter Recalled for Potential Sterility Compromise
Karl Storz Endoscopy America is recalling 27023WU Balloon Catheters because packaging defects may compromise sterility. The recall affects 40 units distributed to five US states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential loss of sterility due to packaging compromise, which is a significant risk but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Karl Storz Endoscopy America Inc has initiated a recall of the 27023WU Balloon Catheter, 3 Fr., sterile, which contains latex. The recall is being conducted because the packaging of these devices may be compromised, which could affect the sterility of the product. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment and allows for simultaneous drainage of urine or infusion of other solutions.
The recall involves 40 units of the device. The affected lots are 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, and 08451. The product was distributed in the United States to Arizona, Florida, Illinois, Indiana, and Texas.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or the distributor in accordance with the recall instructions.
The recalled product
- Product
- 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
- Manufacturer
- Karl Storz Endoscopy America Inc
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lots: 12471
- 12281
- 12271
- 12171
- 12101
- 12051
- 11501
- 11401
- 09471
- 09431
- 09251
- 09201
- 09161
- 09091
- 09071
- 08451.
Distribution
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