Z-0360-2014Class II

Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico...

Name: Z-0360-2014 Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico...
Creator: Salter Labs
Published: 2013-11-01
License: https://open.fda.gov/license/

Salter Labs / initiated 2013-11-01 / Terminated / root cause: labeling and UDI

FDA source

SALTER LABS began a recall of Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA... on 2013-11-01. FDA classified it as Class II and gives the reason as "It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length". 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-0360-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-01
Posted: 2013-11-19
Terminated: 2013-12-17
Recalling firm: Salter Labs
Product: Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received. All customers letters were sent certified mail, return receipt requested.
Quantity in commerce: 91 cases (25 units per case)
Distribution: Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
Product codes and lots: Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0360-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0360-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-19

Product code CCK

K894350Class IISalter Labs Model #4009 Sample LinesSalter Labs / cleared 1989-10-03

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)