CLASS II Device recall · Reported 27 Nov 2013 · FDA Enforcement Report

EtCO2 Sample line 15' (4.6 M) tube, male luer connectors recalled

Salter Labs is recalling EtCO2 Sample line 15' (4.6 M) tube, male luer connectors, distributed in 9 states. The recall was initiated on 1 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: 4515-15-25; lot numbers 071513, 071513A and 120312.

Quantity recalled91 cases (25 units per case)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0360-2014
FDA event ID: 66720
Recalling firm: Salter Labs, Arvin, CA
Classification: Class II
Status: Terminated
Recall initiated: 1 Nov 2013
FDA classified: 19 Nov 2013
Reported: 27 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Nov 2013	Recall initiated by company
19 Nov 2013	Classified by FDA	+18 days
27 Nov 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.

Florida Michigan Missouri Mississippi North Carolina New York Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.

Where was it sold?

Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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