Device Recall Baxter

  • Model / Serial
    all lots within expiration date of the following pre-filled syringes: Code 2K0901: 2 mL in 3 mL syringe Code 2K0903: 3 mL in 6 mL syringe Code K0905: 5 mL in 12 mL syringe Code 2K0906: 10 mL in 12 mL syringe Code 2K6011: 2 mL in 3 mL syringe w/cannula Code 2K6012: 3 mL in 6 mL syringe w/ cannula Code 2K6013: 5 mL in 12 mL syringe w/cannula Code 2K6014: 10 mL in 12 mL syringe w/cannula
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Honduras, Indonesia, Israel
  • Product Description
    0.9% Sodium Chloride Flush Syringe; Baxter Healthcare Corporation, Deerfield, IL 60015; 30 syringes per case
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA

155 devices with a similar name

Learn more about the data here

  • Model / Serial
    product code 2M8063, serial numbers 312424FB, 401424FB, 402089FB, 405111FB, 406060FB, 406067FB, 406154FB, 406155FB, 410334FB, 504036FB, 504053FB, 504061FB,  504378FB, 505328FB, 5090200FB, 5120672FB, 5120673FB, 6010044FB, 6050216FB, 7090392FB, 72000920, 72002220, 7202164Y, 7202357Y, 73041636, 73043106, 73044076, 73045746, 73048047, 73048607, 8070182FB, 93001467, 93007507, 10010241FB, 10100618FB, 10100652FB,  11010414FB, 11030373FB, 11050043FB, 11050487FB, 11050505FB, 11060149FB, 12060080FB, 13020041FB, 13040040FB, 13090060FB, 14020080FB, 13050172FB, 14080040FB.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming
  • Product Description
    Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063
  • Manufacturer
  • Model / Serial
    product code 2M8064, serial numbers RA00449, RA00771, RA01093, RA01103FA, RA01143, RA01212FA, RA01241FA, RA01352, RA01392, RA01471FA, 4020417FA, 4110026FA, 4110599FA, 4111648FA, 5010398FA, 5010588FA, 5010892FA, 5030542FA, 5031363FA, 5041317FA, 5041836FA, 5050032FA, 5101954FA, 5111071FA, 5111215FA, 5111217FA, 6020538FA, 6051302FA, 6110083FA, 6110621FA, 6110976FA, 6112818FA, 6113536FA, 6120726FA, 6120952FA, 6121014FA, 6121201FA, 6121249FA, 62004506, 62009976,62013806, 62020266, 62067349, 62069349, 6208698X, 63106801, 63111022, 63111672, 63157766, 63159996, 63173758, 7120494FA, 8020914FA, 8030070FA, 8060094FA, 8080471FA, 8090732FA, 8090762FA, 8111587FA, 8111640FA, 83003592, 83039198, 83044518, 83055250, 83064210, 83069140, 9030584FA, 9030593FA, 9110819FA, 10091327FA, 10091426FA,10091428FA, 10110600FA, 10111225FA, 10111396FA, 10112596FA, 10113463FA, 10113550FA, 10113557FA, 10120142FA, 11030108FA, 11030281FA, 11030908FA, 11031331FA, 11042552FA, 11042740FA, 11042815FA, 11051333FA, 11052654FA, 11052741FA, 11052809FA, 11052957FA, 11061064FA, 11070997FA, 11072099FA, 11081754FA, 11100082FA, 11111119FA, 11120281FA, 11120313FA, 11120327FA, 11120346FA, 12020834FA, 12010409FA, 12031733FA, 12040163FA, 12041054FA, 12060362FB, 12060972FA, 12061359FA, 12061727FA, 12070800FA, 12080863FA, 12090274FA, 12100402FA, 12101819FA, 12102195FA, 12102656FA, 12102742FA, 12102862FA, 12120472FA, 12121033FA, 13010030FA, 13010283FA, 13070260FA, 13070316FA, 13080047FA, 13100967FA, 13101196FA, 13110190FA, 14010668FA, 14050871FA, 14071117FA, 14071128FA, 14071153FA, 14071166FA, 14091581FA, 14091796FA, 14020391FA, 14020002FA, 15013155FA, 15013208FA, 15050126FA, 15050608FA.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming
  • Product Description
    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product code # 2M8064
  • Manufacturer
  • Model / Serial
    Lot Numbers: 07E037, 07E038, 07E039, 07E055, 07E056, 07E057, 07F015, 07F029, 07F030, 07F039, 07G003, 07G004, 07G043, 07H004, 07H005, 07H006, 07H035, 07H036, 07H037, 07H057, 07H059, 07H061, 07H074, 07J016, 07J018, 07J052, 07J054, and 07K020
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA, Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Portugal, San Marino, Spain, Sweden, United Kingdom, South Africa, Colombia, Argentina, Hong Kong, Australia and New Zealand.
  • Product Description
    Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
  • Model / Serial
    Product code 5C4482, lot number H09E19059.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.
  • Product Description
    Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4482 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
  • Manufacturer
  • Model / Serial
    Product code 5C4483, lot number H09E18044.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.
  • Product Description
    Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
  • Manufacturer
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