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U.S. Department of Health and Human Services

Class 2 Device Recall Salter Labs EtCO2 Sample line

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 Class 2 Device Recall Salter Labs EtCO2 Sample linesee related information
Date Initiated by FirmNovember 01, 2013
Date PostedNovember 19, 2013
Recall Status1 Terminated 3 on December 17, 2013
Recall NumberZ-0360-2014
Recall Event ID 66720
510(K)NumberK894350 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductSalter 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.
Code Information Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.
FEI Number 1314417
Recalling Firm/
Manufacturer		 SALTER LABS
100 Sycamore Rd
Arvin CA 93203-2300
For Additional Information ContactColleen Moyne
760-795-7089
Manufacturer 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 2		Labeling Change Control
ActionSalter 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 in Commerce91 cases (25 units per case)
DistributionDistributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CCK
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