Z-0229-04

ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide

Name: Z-0229-04 ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
Creator: Alcon Laboratories, Inc
Published: 2003-11-18
License: https://open.fda.gov/license/

Alcon Laboratories / initiated 2003-11-18 / Terminated

FDA source

Alcon Laboratories, Inc began a recall of ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide on 2003-11-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0229-04
Status: Terminated
Initiated: 2003-11-18
Posted: 2003-12-17
Terminated: 2004-10-20
Recalling firm: Alcon Laboratories
Product: ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
Product code: LPO Gases Used Within Eye To Place Pressure On Detached Retina
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 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).
Distribution: Germany, Switzerland, and Austria
Product codes and lots: All lots of the German translated patient bracelets

Product code LPO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)