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U.S. Department of Health and Human Services

Class 2 Device Recall Karl Storz Electrode, Roller Ball

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 Class 2 Device Recall Karl Storz Electrode, Roller Ballsee related information
Date Initiated by FirmJune 01, 2009
Date PostedMay 11, 2013
Recall Status1 Terminated 3 on May 13, 2013
Recall NumberZ-1309-2013
Recall Event ID 55358
510(K)NumberK934647 K983569 
Product Classification Resectoscope - Product Code FJL
ProductElectrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Code Information Lot 36833
Recalling Firm/
Manufacturer		 Karl Storz Endoscopy America Inc
2151 East Grand Avenue
El Segundo CA 90245
For Additional Information Contact
818-218-8100
Manufacturer Reason
for Recall		Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.
FDA Determined
Cause 2		Packaging
ActionA Safety Alert dated May 29, 2009 was sent to affected customers. The letter informed them of possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products which may result in airborne contamination. Karl Storz requested consignees to inspect their inventory of the subject products thoroughly and look for small holes in the blister trays. Any identified units should be returned to Karl Storz, and a replacement package (6 units per package) will be provided to at no charge. The Karl Storz Customer Support number 1-800-421-0837 ext. 7577 was provided to obtain a Return Authorization Number (RMA) and arrange replacement. Questions and comments were forwarded to Technical Support at 1-800-421-0837 ext. 5350.
Quantity in Commerce9432 units
DistributionDistributed Nationwide and in Canada.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FJL
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