FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
- Recall number
- Z-3213-2017
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
- Status
- Terminated
- Initiated
- 2017-08-14
- Posted
- not on file
- Terminated
- 2019-06-18
- Reason
- Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
- Root cause
- Under Investigation by firm
- Action
- Smiths Medical sent an Urgent Medical Device Recall letter dated August 7, 2017. The consignees were directed to identify the recalled product, return it to Stericycle, and respond to the recalling firm within 10 days of receipt. For further questions, please call (763) 383-3000.
- Quantity
- 89 units
- Distribution
- INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
- Lot, serial or model codes
- Lot number 3308971
- 510(k) numbers
- ["K962175"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28