Z-2237-2011

Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube...

Name: Z-2237-2011 Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube...
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 Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D)... on 2011-04-19. The reason FDA records is "Complaint received that the product in the box was different from labeled product". 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-2237-2011
Status: Terminated
Initiated: 2011-04-19
Posted: 2011-05-20
Terminated: 2011-08-23
Recalling firm: Salter Labs
Product: Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula. Single Patient Use. Do not Sterilize Salter Labs, 100 W. Sycamore Road, Arvin, CA 93293 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: Complaint received that the product in the box was different from labeled product.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Salter Labs, sent an "URGENT PRODUCT RECALL" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form via fax to 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.
Quantity in commerce: 22,150 pieces
Distribution: Nationwide distribution.
Product codes and lots: Product Code: 4707-7-7-25, Lot code 012411

Product code CCK

K892406Class IIModified Oxygen Delivery/co2 Sample Nasal CannulaSalter Labs / cleared 1989-07-24

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)