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

FDA device recall Z-0229-04 · posted 2003-12-17 · Terminated

Recall details

Recalling firm

Alcon Laboratories, Inc

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.

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).

Root cause

Other

Status

Terminated

Product code

LPO

Distribution

Germany, Switzerland, and Austria

Date initiated

2003-11-18

Date posted

2003-12-17

Date terminated

2004-10-20

Location

Fort Worth, TX