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U.S. Department of Health and Human Services

Class 2 Device Recall IPSAN patient bracelet

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  Class 2 Device Recall IPSAN patient bracelet see related information
Date Initiated by Firm November 18, 2003
Date Posted December 17, 2003
Recall Status1 Terminated 3 on October 20, 2004
Recall Number Z-0229-04
Recall Event ID 27748
Product Classification Gases Used Within Eye To Place Pressure On Detached Retina - Product Code LPO
Product ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
Code Information All lots of the German translated patient bracelets
Recalling Firm/
Manufacturer		 Alcon Laboratories, Inc
6600 South Fwy
Fort Worth TX 76134-2901
Manufacturer Reason
for Recall		 The firm initiated the recall on 11/18/2003 via letters to all consignees. The letter advises physicians to stop using any patient bracelets (blue color) that contain the word 'stickoxid', destroy all blue bracelets, and identify all patients who had either ISPAN gas administered who may still have a bubble present in the eye.
FDA Determined
Cause 2		 Other
Action The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, 'stickoxid', which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (grey) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas).
Distribution Germany, Switzerland, and Austria
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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