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U.S. Department of Health and Human Services

Class 2 Device Recall 27023WU Balloon Catheter

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  Class 2 Device Recall 27023WU Balloon Catheter see related information
Date Initiated by Firm May 31, 2013
Date Posted July 13, 2013
Recall Status1 Terminated 3 on July 15, 2013
Recall Number Z-1728-2013
Recall Event ID 65505
Product Classification Catheter, balloon type - Product Code GBA
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 of urine or infusion of other solutions.
Code Information Lots: 12471, 12281, 12271, 12171, 12101, 12051, 11501, 11401, 09471, 09431, 09251, 09201, 09161, 09091, 09071, 08451.
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy America Inc
15 Wells St
Southbridge MA 01550-4503
For Additional Information Contact
746-708-8440
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Packaging
Action The firm, Karl Storz, sent a "A SAFETY ALERT-ATTENTION NEEDED" letter dated May 31, 2013 to all customers who purchased the 27023WU Balloon Catheter. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and to return the recalled product back to Karl Storz.. The customers were also instructed to complete and fax back the Recall Response Form attached with the safety alert letter at Fax #424-218-8559. If you have any questions, please feel free to call 424-218-8289.
Quantity in Commerce 40 units
Distribution US distribution to: AZ, FL, IL, IN and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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