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U.S. Department of Health and Human Services

Class 2 Device Recall Medley System with EtCO2 Module

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  Class 2 Device Recall Medley System with EtCO2 Module see related information
Date Initiated by Firm July 01, 2019
Create Date August 30, 2019
Recall Status1 Terminated 3 on September 09, 2020
Recall Number Z-2443-2019
Recall Event ID 83296
510(K)Number K031741  
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Code Information Serial #/Model # 15098573 11634567; 15111502 11634567; 15096360 11634567; 15098699 11634567; 15099681 11634567; 15096411 11634567; 15091045 11634567; 15095827 11634567; 15090452 11634567; 15091016 11634567; 15091061 11634567; 15102989 11634567; 15096388 11634567; 15098536 11634567; 15098577 11634567; 15099809 11634567; 15099880 11634567; 15100031 11634567; 15101644 11634567; 15101802 11634567; 15102453 11634567; 15102532 11634567; 15091069 11634567; 15091118 11634567; 15102694 11634567; 15095732 11634567; 15095813 11634567; 15095837 11634567; 15095838 11634567; 15095745 11634567; 15096145 11634567; 15096189 11634567; 15096165 11634567; 15096179 11634567; 15096789 11634567; 15098732 11634567; 15101800 11634567; 15101856 11634567; 15101878 11634567; 15101902 11634567; 15101956 11634567; 15101984 11634567; 15102450 11634567; 15102465 11634567; 15102463 11634567; 15102547 11634567; 15102604 11634567; 15102565 11634567; 15102627 11634567; 15102639 11634567; 15102674 11634567; 15102901 11634567; 15102911 11634567; 15104015 11634567; 15104017 11634567; 15104041 11634567; 15102955 11634567; 15090987 8300ADXEN933; 15091002 8300ADXEN933; 15091053 8300ADXEN933; 15091228 8300ADXEN933; 15091270 8300ADXEN933; 15091272 8300ADXEN933; 15091274 8300ADXEN933; 15091297 8300ADXEN933; 15091311 8300ADXEN933; 15091350 8300ADXEN933; 15091321 8300ADXEN933; 15091347 8300ADXEN933; 15091352 8300ADXEN933; 15095743 8300ADXEN933; 15095794 8300ADXEN933; 15095805 8300ADXEN933 15101540 8300ADXEN933; 14976629 8300ADXEN933   
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact Michelle Badal
858-617-5925
Manufacturer Reason
for Recall		 Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
FDA Determined
Cause 2		 Employee error
Action On July 3, 2019, a "Medical Device Product Notification" letter was sent via FED Ex 2-day delivery with signature required. The letter informs consignees of the following: 1. Customers with the affected serial numbers should call the BD Support Center at 888-562-6018 to schedule service of the devices at the BD Service Depot. 2. BD will contact all affected facilities within 60 days to initiate the return process for the affected EtCO2 modules. BD will recalibrate the EtCO2 modules using a 5% CO2 gas concentration and send the devices back to the customer. 3. The US Food and Drug Administration has been notified of this action. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by: " Web: MedWatch website at www.fda.gov/medwatch " Phone: 1-800-FDA-1088 " Fax: 1-800-FDA-0178, or by "Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 4. Please promptly complete and return the enclosed Customer Response Card to acknowledge receipt of this notification. 5. If you have any questions regarding the products, please contact BD Support Center at 888-562-6018.
Quantity in Commerce 76 EtCO2 units
Distribution US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CCK and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.
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