Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
FDA Recall Z-0260-2007 · Posted 2006-12-07
Advertisement
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJOH
Date Initiated2006-11-17
Date Terminated2007-01-12
Product Quantity5
Reason for Recall
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
Firm Action
The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.
Root Cause
Other
Distribution Pattern
New York-single hospital consignee
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement