Recall Z-0229-04 ยท LPO Gases Used Within Eye To Place Pressure On Detached Retina
Alcon Laboratories, Inc
ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
| Date | Dec 17, 2003 (initiated Nov 18, 2003) |
| Status | Terminated |
| 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). |
| Distribution | Germany, Switzerland, and Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.