Smiths Medical ASD, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot CL47189.
Products Sold
Lot CL47189.
Smiths Medical ASD, Inc. is recalling Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, due to Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY
Page updated: Jan 10, 2026