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Terminated

Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.

FDA Recall Z-0378-2007 · Posted 2007-01-25

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeKAC
Date Initiated2006-12-15
Date Terminated2007-12-04
Product Quantity117

Reason for Recall

The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

Firm Action

Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, Netherlands and United Kingdom.

Official Source

View FDA Recall →

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

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