Recall Z-0360-2014
Salter Labs · initiated November 1, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0360-2014
- Initiated
- November 1, 2013
- Posted by FDA
- November 19, 2013
- Terminated
- December 17, 2013
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Quantity
- 91 cases (25 units per case)
- Distribution
- Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
- Recalling firm
- Salter Labs, Arvin, CA