ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
This recall has been terminated (originally issued December 17, 2003).
- Company
- Alcon Laboratories, Inc
- Recall Initiated
- November 18, 2003
- Posted
- December 17, 2003
- Terminated
- October 20, 2004
- Recall Number
- Z-0229-04
- Firm Location
- Worth, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Germany, Switzerland, and Austria
Lot / Code Info
All lots of the German translated patient bracelets
Root Cause
Other
Action Taken
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).