Device 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.
Z-0360-2014
Product summary
- Firm
- SALTER LABS
- Event
- Event 66720
- Status
- Terminated
- Classification
- Class II
- Quantity
- 91 cases (25 units per case)
- Official record key
device-enforcement:Z-0360-2014
Official wording
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.
Code information: Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.
Distribution pattern: Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
Derived failure modes
-
Unknown
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.