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  • Dispositivo 128
  • Fabricante 31827
  • Evento 155
  • Implante 27
Celerity PICC Tip Confirmation System
  • Modelo / Serial
    AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D; medCOMP UPN MRLCA000, Batch/Lot Number MBVT240.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
  • Descripción del producto
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)
  • 1 Event
    • Retiro De Equipo (Recall) de Celerity PICC Tip Confirmation System
Device Recall Lyric Hearing Aid
  • Modelo / Serial
    All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution only in US ( nationwide). No foreign consignees involved.
  • Descripción del producto
    InSound Medical, Inc, Lyric in-canal hearing aid.
  • Manufacturer
    InSound Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Lyric Hearing Aid
Device Recall Nasal Splint
  • Modelo / Serial
    All Lots of alcohol pad supplied in the following kits:  REF: 1528116 (sm):  29435400 56546900 59577800 62129000 64918600 51350700 56622000 59748100 62491500 65206800 53799600 57312400 59887500 62647600 65482100 54038700 57520700 60156800 62892100 66033700 54597800 57540700 60494800 63137800 66336700 54991100 57676700 60708300 63481200 66814000 55301000 58005700 61032000 63707800 67838900 55610900 58188100 61532100 63937700 67940600 56072200 58970000 61888600 64257500 68658000 56229700 59328700 61938500 64615900 68918600.   REF 1528126 (med):  36361500 54818200 58360300 62548400 65917800 43037100 54863900 58646400 62821300 66124900 44818300 55151800 58687600 63159400 66474100 45129900 55242200 59075900 63338600 66933800 50667000 55409500 59619200 63519800 67255300 51270000 56072400 59886900 63852400 67577700 52341200 56307900 60519300 63852600 67815500 52669500 56546500 61026800 64144700 67877800 53120100 56893600 61241400 64615400 67878000 53381200 57094500 61419000 64758400 68567600 53712500 57637600 61905500 64863900 68935700 53799500 57943700 61938600 65206000 68959300 54501300 58004000 62293100 65206100.   REF 1528136 (lg):  31477100 54817800 59328800 61888900 65482000 39187500 54863300 59513800 62295000 65671400 44987900 54905400 59747800 62704800 66288600 51897300 56309000 59887200 62821400 66996400 52303000 56372500 60113000 63475900 67081600 52801000 56495500 60225500 63775400 67814800 52981200 57312500 60494500 64332900 68534100 53158900 57385900 60513700 64625000 68823100 53711700 58189000 61026400 64748800 68843200 53800300 58970100 61359800 64918100  53896300 59076300 61639600 65206900.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Singapore, Canada, Belgium, Croatia, Cyprus, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Martinique, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, Taiway, Korea, Puerto Rico, and Costa Rica.
  • Descripción del producto
    An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. || An external nasal splint is a rigid or partially rigid device intended for the use externally for immobilization of part of the nose. || Recall of Alcohol Pads contained in the following kits distributed by Medtronic: || ***REF 1528116***External Nasal Splint Kit, Small***X5***. || ***REF 1528126***External Nasal Splint Kit, Medium***X5***. || ***REF 1528136***External Nasal Splint Kit, Large***X5***. || RECALLED PRODUCT - Front: || ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. || RECALLED PRODUCT - Back: || ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.*** || Each Kit Includes the dorsum pad (splint), an alcohol sponge (prep pad), skin preparation and skin closure tapes (steri-strips).
  • Manufacturer
    Medtronic Xomed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Nasal Splint
Device Recall Nasal Splint
  • Modelo / Serial
    All Lots of alcohol pad supplied in the following kits:  REF: 1529100 (sm):  35264300 56072300 59748000 63338900 67148300 45672700 56229600 59887300 63390900 67187000 46559700 56893700 60114300 63594300 67255600 52740600 57094300 60494400 63937800 67685400 53030400 57501500 60748000 64257100 67732700 53120200 57637900 61031000 64617300 68011400 53593000 57943500 61417800 64917800 68051600 53799400 58177600 61903200 65072500 68124600 53960600 58414100 62128800 65482200 68214500 55026000 58969400 62487300 65723200 68779200 55301100 58971000 62988600 66033900  55746000 59329100 63138100 66102500.   REF: 1529110 (med):  32765300 55409300 59620200 62294300 65332500 36977500 55610700 59747600 62451300 65629400 45275000 55846300 59826600 62486600 65836900 45672800 56071000 60114100 62849200 65954400 46725100 56308700 60156500 62892000 66006700 51269600 56546300 60225400 63075400 66187600 53119700 56840300 60494300 63265400 66259300 53304100 56978500 60495500 63339200 66434800 53411800 57166400 60514000 63391000 66521600 53423800 57341200 60747600 63475600 67071500 53938600 57501400 60840900 63772200 67326300 53962000 57676800 61030800 63852800 67500900 54038800 58187700 61417600 63937600 67873100 54359500 58969000 61570900 64257400 68657800 54597900 59076100 61639500 64333000 68842900 54864100 59291100 61858800 64918000  54905500 59513600 62128600 65139000.   REF 1529120 (lg):  46873800 54863800 58189400 61906500 64918400 47201900 55409700 58970200 62128900 65481900 51303300 55801200 59076400 62451600 65671500 52930000 55846600 59577300 62491600 66034500 53064800 56231100 59826300 63076000 66684000 53158700 56546800 60156900 63176600 68873800 53353000 56893800 60494200 63390800  53800000 57094000 60748100 63475700  54170800 57501200 61031400 63708700  54352600 58177900 61639100 64332700
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Singapore, Canada, Belgium, Croatia, Cyprus, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Latvia, Martinique, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, Taiway, Korea, Puerto Rico, and Costa Rica.
  • Descripción del producto
    Recall of Alcohol Pads contained in the following kits distributed by Medtronic: || ***REF 1529100***Thermasplint Kit, Small***X5***. || ***REF 1529110***Thermasplint Kit, Medium***X5***. || ***REF 1529120***Thermasplint Kit, Large***X5***. || RECALLED PRODUCT - Front: || ***Allegiance Alcohol Prep Pad***Antiseptic, Medium, 2-ply, Saturated with 70% isopropyl alcohol, For External Use Only*** Cat. 40000-090***NDC 63517-300-10***Qty. 1 ea***Distributed by: Cardinal Health McGraw Park, IL 60085-6787 USA, Made in USA, Rev. D 12/04***Cardinal Health***. || RECALLED PRODUCT - Back: || ***Drug Facts***Active ingredient Isopropyl Alcohol, 70% v/v....Purpose Antiseptic***Use For preparation of skin prior to injection***Warnings For external use only. Flammable, keep away from fire or flame. Do not use - with electrocautery procedures - in the eyes. Stop use if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.*** Directions Wipe injection site vigorously and discard.***Inactive ingredient purified water.***
  • Manufacturer
    Medtronic Xomed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Nasal Splint
ENT Pack
  • Modelo / Serial
    Lot numbers 140513090 140613609 140714182 140814653
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to Florida, New York and Puerto Rico..
  • Descripción del producto
    ENT Pack, Catalog number 900-1482. || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ENT Pack
Ear Pack
  • Modelo / Serial
    Lot numbers 140412835 140512993 140613955 140714236 140814770
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to Florida, New York and Puerto Rico..
  • Descripción del producto
    Ear Pack, catalog #900-2234 || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Ear Pack
Doyle AbsorbENT Nasal Pack w/airway & string
  • Modelo / Serial
    160889, 161354
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed to CA.
  • Descripción del producto
    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. || Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
  • Manufacturer
    Summit Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Doyle AbsorbENT Nasal Pack w/airway & string
Gyrus ACMI Round Cutting Burrs
  • Modelo / Serial
    Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    NM, MI, and TX EU, Australia, Japan, and Hong Kong
  • Descripción del producto
    Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
  • Manufacturer
    Gyrus ACMI, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Gyrus ACMI Round Cutting Burrs
Ear/Ulcer Bulb Syringe
  • Modelo / Serial
    Catalog # 4173, Lot number 038594A1.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.
  • Descripción del producto
    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
  • Manufacturer
    Medegen Medical Products, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Ear/Ulcer Bulb Syringe
Device Recall 2.0x7mm Fossa Xdrive screws
  • Modelo / Serial
    Lot # 233270
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was distributed to one distributor in Argentina.
  • Descripción del producto
    Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA SCREW 5/PKG***2.0 MM X 7.0 MM***". || Bone screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. These screws are to be used with our TMJ (Temporal Mandibular Joint) implants.
  • Manufacturer
    Biomet Microfixation, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall 2.0x7mm Fossa Xdrive screws
Device Recall Leica M822 Surgical Microscope
  • Modelo / Serial
    Article 10448446, serial numbers 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004. The corrected units will have controller software version MDC V3.6 pack G
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: California, Colorado, Illinois, New York, Oregon, South Carolina; and countries of: Australia, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey.
  • Descripción del producto
    Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland || The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
  • Manufacturer
    Leica Microsystems, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Leica M822 Surgical Microscope
Device Recall Summit Medical, BL2006, Myringotomy Lance (Juvenile) Blade
  • Modelo / Serial
    Lot No. 121012
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in MS, NY, PA and TX.
  • Descripción del producto
    Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 || Use to make an incision in the tympanic membrane.
  • Manufacturer
    Summit Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Summit Medical, BL2006, Myringotomy Lance (Juvenile) Blade
Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE
  • Modelo / Serial
    JC477666
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
  • Descripción del producto
    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 || Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
  • Manufacturer
    Gyrus Acmi, Incorporated
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE
Device Recall Tra, Surgical, ENT
  • Modelo / Serial
    ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray  * instrument set that includes the identified tray
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Morocco, Netherlands, Nigeria, Portugal, Qatar, Reunion, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Australia, New Zealand, Singapore, Thailand, Vietnam, China, Hong Kong,Taiwan, Korea, Japan, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, and Venezuela.
  • Descripción del producto
    Tray Surgical, ENT (various instrument trays) || Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
  • Manufacturer
    Medtronic Xomed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Tra, Surgical, ENT
Device Recall Customed
  • Modelo / Serial
    Product code 900-1482, 39 lots: 110102428 110112608 110123088 111010049 111020265 111030581 111040888 111051317 111061497 111071865 111082190 111092354 111102683 111113009 111123347 112010050 112020371 112030620 112041188 112051766 112062419 112083396 112093898 112124950 112125282 113025940 113036669 113047197 113067888 113068256 113078256 113109732 131210747 140111083 140211641 140312070 140312453 140513090 140613609
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    E..N.T. PACK - || (5) SPONGE TONSIL 7/8 XRD || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED L/F || (1) TUBE SUCTION CONNECT %" X 12' L/F || (1) CAUTERY TIP POLISHER LIF || (1) SUTURE BAG FLORAL || (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) CAUTERY PENCIL HAND SWITCHING || (2) ABSORBENT TOWELS 15" X 20" L/F || (1) DRAPE SHEET 41 " X 58" SMS L/F || (1) EAR/ULCER SYRINGE 2oz LIF || (2) MEDICINE CUP 2oz || (1 0) GAUZE SPONGE 4" X 4" 16PL Y || (1) *Pr. SURGICAL GLOVES #7% POWDER || (1) *Pr. SURGICAL GLOVES #7 POWDER || (9) LABEL FOR SKIN MARKER || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Customed
Device Recall Customed
  • Modelo / Serial
    Product code 900-2234, 8 lots 112030726 113088792 113109792 131110112 131110338 140211660 140412835 140512993
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    EAR PACK || CONTENTS: || ( I ) B LADE SU RG ICA L # 15 CARBON STEEL || ( I ) EMESI S BASIN lO in 700cc || ( I ) GOWN XL SMS IM P. REINFORCED || ( I ) NEEDLE HYPODERM IC 1 8G X I 'h || ( I ) WASH BASIN ROUND 6QT || ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT || (I) STERI STR I P CLOSURE 'h" X 4" || ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK || (2) SYRINGE I ML WITHOUT NEEDLE LILOCK || (I) CAUTERY TIP POLISHER || (I) SHEET ENT SPLIT 110" X 77" SMS || ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V || (2) LITE GLOVE || (1 2) TOWELS CLOTH HUCK (BLUE) || ( I ) TUBE SUCTION CONNECT W' X 1 2' || (I) EAR ULCER SYRINGE 2oz || (I) TABLE COYER REINFORCED 50" X 90" || ( I) UTILITY BOWL 16oz || (4) APPLICATOR COTTON 6" WOOD || (2) STRJPS TAPE 24" X 4" || ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 || ( I ) MAYO STAND COYER REINFORCED || ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK || ( I ) MAYOTRAY SMALL || ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 || ( I ) TI ME OUT BEACON NON WOVEN || (I) BLADE M IN IATURE CARBON STEEL || (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD || (I) SK I N MARKER INK W/8 LABEL || (2) NEEDLE HYPODERM I C 27G X I W' || ONE PACK WET SK IN W ITH CONTENTS: || ( I ) WRAPPER SMS 30" X 30" || (2) COTTON TIP APPLICATOR 6" WOOD || (2) GLOVE MED FREETOUCH VYNIL P/F || (6) SPONGE W ING SMALL || (4) TOWELS ABSORBENT 1 5" X 20" || (3) TIP ABSORB. APPLICATOR STI CK SPONGE || ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE || (I) PVP SCRUB SOLUTION 4oz. BOTTLE || (I) TRAY 3/COMPARTMENT || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Customed
Device Recall Customed
  • Modelo / Serial
    Product code 900-2423 ,3 lots 131010019 140111210 140312131
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    EAR PACK || CONTENTS: || (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc || (2) LABEL FOR SKIN MARKERS || ( I) NEEDLE HYPODERMIC 1 80 X I Y, || ( I) WASI-l BASIN ROUND 6QT || (I) INSTRUMENT POUCH 7 X I I 2 COMPART || (I) STRIP STER I CLOSURE W' X 4" LIF || (I) SYRINGE 3cc W/0 NEEDLE LILOCK L/F (2) SY RI NGE I ML W/0 NEEDLE LILOCK LIF ( I ) CAUTERY POLISHER TI P LIF || ( I) SH EET ENT SPLIT 11 0 X 77 || (2) LITE GLOVE || (2) NEEDLE H YPODERM IC 27G X I \!..'' || (1 2) TOWELS CLOTH HUCK (BLUE) || ( I ) TUBE SUCTION CONNECT.'!." X 12' L/F ( I ) EAR ULCER SYRINGE 2oz LIF || ( I ) TABLE COYER REINFORCED 50" X 90" LIF ( I ) UTILITY BOWL 1 6oz LIF || (4) COTrON APPLICATOR 6" WOOD || ( I ) INSTRUMENT WIPE I MM 8.25 X 8.25 || ( I ) MAYO STAND COYER REINFORCED LIF || ( I ) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF ( I ) SKIN MARK ER W/R ULER || ( I ) SYRINGE IOcc W/0 NEEDLE LILOCK LIF || ( I ) TRAY MAYO SMALL || ( I ) SYRING E IOcc TI P CONTROL LILOCK LIF || ( I ) DRAPE MICROSCOPE ZEI SS || ( I ) TOWELS ABSORBENT 1 5'' X 20" LIF || ( I ) TIME OUT BEACON NON WOV EN ST LIF || ( I ) BLADE M INUATURE CARBON STEEL || ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF || ( I ) NEEDLE BLUNT FI LL 1 80 X I Y, || (2) SCALPEL SAFETY WEIGHTED # 1 5 || ( I ) GOWN SURG, I MP ER. M I CROCOOL LG E (2) GOWN XL SURG ICAL MICROCOOL || ( I ) MERLINO SKIN PREP APPLIC. 39ML LIF || ( I ) WRAPPER 24" X 24" || WET SKIN PACK CONTA INING: ( I ) WRAPPER 30" X 30" || ( I ) TRAY 3/COMPARTM ENT || ( I ) PYP SCRUB SOLUTI ON 4oz. BOTrLE || (3) TI P ABSORBENT APPLICATOR STICK SPONGE || (3) TOWELS ABSORBENT 15" X 20" L/F (6) SPONGE WING SMALL LIF || (2) GLOVE MED FREETOUCI-1 VYN I L P/F || (2) COTrON APPLICATOR 6" WOOD || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Customed
Device Recall Customed
  • Modelo / Serial
    Product code 900-2498 , 4 lots 112020356 112051968 112072870 113078527
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    EENT PACK I || CUSTOMED || CONTENT: || (2) TOWEL ABSORBENT 15" X 20" || (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL || (1) SHEET ENT SPLIT 110" X 77" SMS || (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" || (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Customed
Device Recall AquaStar
  • Modelo / Serial
    Serial numbers: 1FX/17548/05,1GV/17548/01, 1GV/17548/02, 1GV/17548/03, 1GV/17548/04, 1GW/17549/01, 1GW/17549/02, 1GW/17549/07, 1GW/17549/08 and 1GW/17549/10.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (New York and Pennsylvania), Canada, Egypt, Korea, Poland and South Africa.
  • Descripción del producto
    AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium. || The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus.
  • Manufacturer
    Micromedical Technologies, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AquaStar
Device Recall OCM Cutting Burrs (Cutters)
  • Modelo / Serial
    Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in the states of KY and TX.
  • Descripción del producto
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OCM Cutting Burrs (Cutters)
Device Recall OCM Cutting Burrs (Cutters)
  • Modelo / Serial
    Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution in the states of KY and TX.
  • Descripción del producto
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD || Product Usage: || The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
  • Manufacturer
    The Anspach Effort, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall OCM Cutting Burrs (Cutters)
Device Recall Cytosponge Cell Collection Device
  • Modelo / Serial
    Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Descripción del producto
    Covidien Cytosponge Cell Collection Kit. || Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. || Item code CYTO-KIT-R || Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.
  • Manufacturer
    Covidien, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cytosponge Cell Collection Device
Device Recall Cytosponge Cell Collection Device
  • Modelo / Serial
    Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Descripción del producto
    Covidien Cytosponge Cell Collection Device. || Item code CYTO-101-01. || Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
  • Manufacturer
    Covidien, LLC
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cytosponge Cell Collection Device
Device Recall endotrachial tube
  • Modelo / Serial
    All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
  • Descripción del producto
    NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
  • Manufacturer
    Medtronic Xomed, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall endotrachial tube
Device Recall SpineWave
  • Modelo / Serial
    Lot Codes: 092514Z, 120814A, 011415H and 022415F
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
  • Descripción del producto
    Spine Wave Access Kit, Catalog Number 10-1530 || Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. || Product Usage: || The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
  • Manufacturer
    Spine Wave, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall SpineWave
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.