FDA Medical Device Recalls (openFDA)
SALTER LABS: 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.
- Recall number
- Z-0360-2014
- 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.
- Status
- Terminated
- Initiated
- 2013-11-01
- Posted
- 2013-11-19
- Terminated
- 2013-12-17
- Reason
- 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
- 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
- 91 cases (25 units per case)
- Distribution
- Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
- Lot, serial or model codes
- Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.
- 510(k) numbers
- ["K894350"]
- 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