Recall Z-0360-2014— SALTER LABS
Class II · Terminated
Class II FDA medical device recall by SALTER LABS, initiated 2013-11-01, terminated 2013-12-17. It names one FDA 510(k) clearance: K894350. 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.. 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..
- Recalling firm
- SALTER LABS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-01
- Terminated
- 2013-12-17
- Firm location
- Arvin, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.