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U.S. Department of Health and Human Services

Class 2 Device Recall ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery

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 Class 2 Device Recall ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Deliverysee related information
Date Initiated by FirmDecember 07, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on January 09, 2012
Recall NumberZ-0605-2012
Recall Event ID 60658
510(K)NumberK892406 
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
ProductETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203
Code Information Lot 090610
Recalling Firm/
Manufacturer		 SALTER LABS
100 Sycamore Rd
Arvin CA 93203-2300
For Additional Information ContactMichale Shoup
661-854-6871
Manufacturer Reason
for Recall		Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).
FDA Determined
Cause 2		Process control
ActionThe firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.
Quantity in Commerce240 cases
DistributionNationwide Distribution -- TX and VA.
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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