Device Recall Customed

  • Modelo / Serial
    Product code 900-2122, 1 lot: 112124868
  • Clasificación del producto
  • 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
    NEURO SPINE PACK || CONTENTS: (1) SUTURE BAG FLORAL LIF || (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF || (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF || (2) SPECIMEN CONTAINER 4oz W/LID & LABEL || (2) CUP MEDICINE 2oz UF || (2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL || (20) GAUZE SPONGE 4" X 4" 16ply XRD UF || (5) SPONGE LAP PREWASH 18"X 18" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF || (1) YANKAUER SUCT. TUBE W/0 VENT LIF || (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) POLISHER CAUTERY TIP LIF || (2) PENCIL CAUTERY HAND SWITCHING LIF || (1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP || (2) BLADE SURG #15 CARBON STEEL || (1) PK.STRIP SURGICAL %" X 6" COTTON (1) PK.STRIP SURGICAL Y4" X 6" COTTON (10) GAUZE SPONGE 4" X 4" 16ply || (1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt || (4) SHEET DRAPE 42" X 57" SMS LIF || (2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz. || (2) SYRINGE EAR/ULCER 2oz LIF || (2) BLADE EXTENDED ELECTRODE || (2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR || (1) STRIP SURGICAL 'I"X 6" || (2) GOWN XL SMS IMPERV. REINFORCED UF || (1) CORD BIPOLAR FIRCEPS || (4) TOWEL CLOTH HUCK (WHITE) || (2) DRESSING OPSITE POST PO 2%" x 2" (2) POUCH INSTRUMENT 7 X 11 || (1) MAYO TRAY LARGE || (1) MAYO STAND COVER REINFORCED UF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

331 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001296 || PREMIUM LAPAROTOMY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
  • Modelo / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900169 || UNIVERSAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
  • Modelo / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 9001738 || UROLOGY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
  • Modelo / Serial
    LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900010 SUTURE REMOVAL KIT || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
  • Modelo / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed only in Puerto Rico.
  • Descripción del producto
    Catalog Number: 900012 OB SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
  • Manufacturer
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