FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
- Recall number
- Z-0072-2019
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
- Status
- Terminated
- Initiated
- 2018-07-06
- Posted
- not on file
- Terminated
- 2019-04-30
- Reason
- "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
- Root cause
- Labeling design
- Action
- The recalling firm issued an Urgent Medical Device Recall letters dated July 6, 2018 via UPS tracked hard-copy mailing The letter identified the affected product, problem and actions to be taken. Customers were requested to return affected products using the enclosed shipping label. For questions email Stericycle at SmithsMedical7434@stericycle.com.
- Quantity
- 2,550 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.
- Lot, serial or model codes
- Lot number 1705151A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAT
- 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