FDA Medical Device Recalls (openFDA)
Salter Laboratories, Division of Regulatory Affairs: Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.
- Recall number
- Z-2242-2011
- Recalling firm
- Salter Laboratories, Division of Regulatory Affairs
- Product
- Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not sterilize. Used to deliver supplemental oxygen or airflow to a patient or person in need of respiratory help.
- Status
- Terminated
- Initiated
- 2011-04-19
- Posted
- 2011-05-23
- Terminated
- 2011-08-23
- Reason
- One complaint received of product in box different from what was on label.
- Root cause
- Other
- Action
- Salter Laboratories sent a URGENT PRODUCT RECALL NOTIFICATION letter dated April 19, 2011, certified mail to all of the affected consignees, along with a RECALL EFFECTIVENESS CHECK FORM to acknowledge receipt of this communication. It was reported that a package labeled 1600-14, Adult Nasal Cannula actually contained a 25-foot length of tubing and has determined that additional product may have been incorrectly labeled in this manner. No illness or injury would result from this product mix-ups. Should you have any questions, please contact Salter Laboratories at 1-800-235-4203.
- Quantity
- 3500 pieces
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of South America.
- Lot, serial or model codes
- Product code 1600-14-50, Lot number 032210
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 1314417
- Firm city
- Arvin
- Firm state
- CA
- 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