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Terminated

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

FDA Recall Z-0229-04 · Posted 2003-12-17

Recalling FirmAlcon Laboratories, Inc
Recall StatusTerminated
Product CodeLPO
Date Initiated2003-11-18
Date Terminated2004-10-20

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.

Firm 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).

Root Cause

Other

Distribution Pattern

Germany, Switzerland, and Austria

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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