FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
- Recall number
- Z-1732-2019
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
- Status
- Terminated
- Initiated
- 2019-02-11
- Posted
- not on file
- Terminated
- 2020-11-02
- Reason
- Packaged with an incorrect size inner cannula.
- Root cause
- Error in labeling
- Action
- During the week of February 11, 2019, the firm sent URGENT MEDICAL DEVICE FIELD SAFETY NOTICE emails to their consignees advising them to check their stock, complete an enclosed. INSTRUCTIONS TO CUSTOMERS: 1.Locate and determine the number of affected products in your possession. (Product Number: 100/856/080 Lot Number: 3578884) 2.Complete the attached Response Form within 10 days and return it to fieldactions@smiths-medical.com, even if you do not have any of the affected product in your possession. 3.Return affected product to Stericycle utilizing the pre-paid shipping labels included with this notice. Include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at fieldactions@smiths-medical.com. FIELD SAFETY NOTICE RESPONSE FORM and return an affected devices to Stericycle. The emails also instructed distributors to conduct a subrecall.
- Quantity
- 7,840
- Distribution
- Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland
- Lot, serial or model codes
- Item code/product number: 100/856/080 lot number: 3578884
- 510(k) numbers
- ["K030381"]
- PMA numbers
- not on file
- Product code
- BTO
- 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