Z-2242-2011

Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not...

Name: Z-2242-2011 Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube. Single Patient use. Do not...
Creator: Salter Laboratories, Division of Regulatory Affairs
Published: 2011-04-19
License: https://open.fda.gov/license/

Salter Labs / initiated 2011-04-19 / Terminated / root cause: labeling and UDI

FDA source

Salter Laboratories, Division of Regulatory Affairs began a recall of 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... on 2011-04-19. The reason FDA records is "One complaint received of product in box different from what was on label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2242-2011
Status: Terminated
Initiated: 2011-04-19
Posted: 2011-05-23
Terminated: 2011-08-23
Recalling firm: Salter Labs
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: One complaint received of product in box different from what was on label.
Root cause tag: labeling and UDI
FDA 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 in commerce: 3500 pieces
Distribution: Worldwide Distribution - USA (nationwide) and the country of South America.
Product codes and lots: Product code 1600-14-50, Lot number 032210

Product code CCK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)