FDA Medical Device Recalls (openFDA)
Alcon Laboratories, Inc: ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
- Recall number
- Z-0229-04
- Recalling firm
- Alcon Laboratories, Inc
- Product
- ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
- Status
- Terminated
- Initiated
- 2003-11-18
- Posted
- 2003-12-17
- Terminated
- 2004-10-20
- Reason
- 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.
- Root cause
- 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).
- Quantity
- not on file
- Distribution
- Germany, Switzerland, and Austria
- Lot, serial or model codes
- All lots of the German translated patient bracelets
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LPO
- Firm FEI
- 1610287
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28