Device Recall CareFusion

  • Model / Serial
    All lots of the following products:   1) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10127-4H1 ; 2) CIRCUIT RESP INFANT 4FT 30/CS , Product Code 10331N-4S2 ; 3) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10351-4H2 ; 4) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10387-4S2 ; 5) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 10392-503 ; 6) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10485-4H2 ; 7) CIRCUIT INFANT INSP LINE HTD 8FT 30/CS , Product Code 10520-504 ; 8) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10555-4S2 ; 9) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code 10680-504 ; 10) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10706-4S2 ; 11) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10790-4S2 ; 12) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10814-4S2 ; 13) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 10849-4S2 ; 14) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 10865-4H2 ; 15) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 10868-4S2 ; 16) CIRCUIT RESP DISP INF HTD 30/CS , Product Code 1175-4H2 ; 17) CIRCUIT RESP INFANT DUAL DISP 30/CS , Product Code 1208-4H1 ; 18) CIRCUIT RESP INFANT DISP 30/CS , Product Code 1553-4H1 ; 19) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 1815-409 ; 20) CIRCUIT RESP INFANT 3FT HTD HI FI 30/CS , Product Code 1998-4H1 ; 21) INFANT RESP CIRC HTD 4 FT. , Product Code 2119-4S2G ; 22) INFANT RESP CIRC HTD 4 FT. , Product Code 2120-4S2G ; 23) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 4319-4H2 ; 24) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4326-4H2 ; 25) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4652-501 ; 26) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4677-4H2 ; 27) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 4875-4H2 ; 28) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5665-4H2 ; 29) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 5682-409 ; 30) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5732-4H1 ; 31) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 5868-4H2 ; 32) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6002-4H2 ; 33) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6040-501 ; 34) CIRCUIT RESP INFANT PV HTD 5FT 30/CS , Product Code 6074-4H1 ; 35) CIRCUIT RESP PED 7FT HTD 20/CS , Product Code 6274-H12 ; 36) CIRCUIT RESP PED 7FT HTD 20/CS , Product Code 6301-H12 ; 37) INFANT RESP CIRC HTD 4 FT , Product Code 6313-501 ; 38) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 6459-4H2 ; 39) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6485-4H2 ; 40) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 6588-4H2 ; 41) WYE KIT INFANT 30/CS , Product Code 6603-504 ; 42) CIRCUIT INFANT 6FT HTD INSP LINE 30/CS , Product Code 6862-504 ; 43) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 6921-4H2 ; 44) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 6942-4H2 ; 45) CIRCUIT INFANT 4FT HTD 30/CS , Product Code 7100-4S2 ; 46) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7147-4S2 ; 47) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7156-4S2 ; 48) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7184-4S2 ; 49) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7206-4S2 ; 50) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 7213-4S2 ; 51) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7354-4S2 ; 52) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7395-4S2 ; 53) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7407-4S2 ; 54) CIRCUIT RESP INFANT 3FT HTD 30/CS , Product Code 7431-4S2 ; 55) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7441-4S2 ; 56) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7483-4S2 ; 57) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7526-4S2 ; 58) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 7575-4S2 ; 59) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 7582-4S2 ; 60) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 7588-4S2 ; 61) INFANT INSP LINE HTD 30/CS , Product Code 775687-101 ; 62) INFANT INSP LINE HTD 30/CS , Product Code 775687-102 ; 63) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9052-4S2 ; 64) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9053-4S2 ; 65) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9054-4S2 ; 66) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code 9055-4S2 ; 67) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9056-4S2 ; 68) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code 9058-4S2 ; 69) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC41-12010 ; 70) CIRCUIT RESP INFANT 40IN HTD 30/CS , Product Code RC41-12027 ; 71) CIRCUIT RESP INFANT 40IN HTD 30/CS , Product Code RC41-18039 ; 72) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC41-18052 ; 73) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC41-18060 ; 74) CIRCUIT INFANT INSP LINE HTD 5FT 30/CS , Product Code RC51-12002 ; 75) CIRCUIT RESP INFANT 5FT HTD 30/CS , Product Code RC51-12074 ; 76) CIRCUIT RESP INFANT 4FT HTD 30/CS , Product Code RC51-18004 ; 77) CIRCUIT NEONATE 4FT HTD W/ 30/CS , Product Code RT4851-00 ; 78) CIRCUIT NEO 4FT HTD W/12IN REMOTE 30/CS , Product Code RT4851-12 ; 79) CIRCUIT NEO 4FT HTD W/18IN REMOTE 30/CS , Product Code RT4851-18
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland.
  • Product Description
    CareFusion AirLife Heated Infant Breathing Circuit || Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Carefusion 2200 Inc, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog Number 3910
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.
  • Product Description
    CareFusion Vital Signs LightWand Stylet. || A device inserted into an endotracheal tube to aid in the intubation procedure.
  • Manufacturer
  • Model / Serial
    Catalog Number 3960
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.
  • Product Description
    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
  • Manufacturer
  • Model / Serial
    9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518 12918611 12919079 12921157 13034011 13034375 13038124 13050300 13050648 13051034 13061112 13072829 13075412 13077962 13088823 13106029 13106030 13106138 13106140 13122164 13122401 13122402 13122936 13136786 13141565 13142603 13143660 13143809 13143889 13167255 13169672 13173261 13177210 13178248 13178389 13178391 13178512 13178968 13178969 13186760 13187737 13188106 13189792 13190670 13216601 13220274 13316434 13316444 13316453 13316473 13316496 13317481 13317552 13317553 13457448 13463929 13464899 13469917 13470004 13470021 13476713 13476912 13477643 13480785 13482441 13482518 13489475 13491251 13521218 13559325 13559686 13569291 13582129 13602388 13621652 13621847 13622337 13624519 13628251 13628876 13628877 13628918 13629153 13658756 13732201 13744088 13781347 13782359 13796475 13809762 13813539 13818275 13853185 13853375 13858182 13858798 13858976 13862567 13867168 13895850 13895989 13896107 13896108 13896110 13896347 13896456 13896669 13896747 13896748 13910604 13922145 13951711 13994625 13995332 14000190 14006401 14035430 14036040 14084571 14084629 14126982 14126990 14151686 14152555 14172846 14190913 14228679 14235981 14253982 14258801 14259542 14280651
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution.
  • Product Description
    Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
  • Manufacturer
  • Model / Serial
    Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
  • Product Description
    DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. || Designed to retract or elevate organs and tissue to provide better visualization access.
  • Manufacturer
  • Model / Serial
    tray catalog number 4420. tray lot numbers 0000319389, 0000321446, 0000323733, 0000326090, 0000328468, 0000330882, 0000333747, 0000336418, 0000336443, 0000340606, 0000344792, 0000349464, 0000354078, 0000354079, 0000358785, 0000367470, Y11Cl711, Y11C2202, Y11C3733, Y11C3751, Y11D0544
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Arizona, California, Colorado, Connecticut, Florida, Illinois, Missouri, Nebraska, Nevada, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah and Virginia.
  • Product Description
    Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4420 || The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.
  • Manufacturer
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