Device Recall Customed

  • Modelo / Serial
    Product code 900-1091, 56 lots: 110020286 110030631 110040867 110051180 110071617 110081956 110092110 110092379 110112598 110123050 111010018 111020258 111020449 111030543 111051225 111051262 111061481 111071752 111071879 111082042 111092470 111102655 111112944 111112979 111123313 112010019 112020307 112030825 112041390 112041451 112051726 112062316 112072825 112083159 112083381 112093855 112124920 113015425 113025927 113026164 113036314 113047314 113057381 113057855 113078235 113078673 113099267 131110152 131110594 131210957 140111404 140211917 140312390 140412827 140513064 140513451
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿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
    PERY GYN PACK- CUSTOMED- || (1) DRAPE ABDOMINAL WITH TAPE UF || (1) TOWEL ABSORBENT 15" X 20" UF || (2) LEGGINGS W/7" CUFF 30" X 42" || (1) TABLE COVER REINFORCED 44" X 78" UF || (1) DRAPE UNDERBUTTOCK WITH POUCH || 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
    Product code 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿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
    LAPAROSCOPIA COLORECTAL PACK || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 26ml || (4) DRAPE UTILITY WITH TAPE || (1) TOWELS ABSORBENT 15" X 20" || (2) LEGGINS W/7" CUFF 30" X 42" || (1) BLADE SURGICAL #15 STAINLESS STEEL || (1) BLADE SURGICAL #11 STAINLESS STEEL || (1) GOWN IMPERV. EXTRA REINFORCED XLG || (1) GOWN LGE STANDARD SMS VELCRO NECK || (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (2) UTILITY BOWL 16oz || (2) STERI STRIP CLOSURE W' X 4" || (1) ACTIFOG W/FOAM PAD SOLUTION || (1) TABLE COVER REINFORCED 50" X 90" || (1) MAYO STAND COVER REINFORCED || (1) NEEDLE ULTRA VERES 120MM || (1) STAPLE ARTICULATING ECHEL 60MM || (1) RELOAD WHITE 60MM ECHELON || (1) RELOAD BLUE 60MM ECHELON || (2) CANNULA 5MM XCEL SLEEVES || (1) TROCAR 5MM BLADELE WITH STAB SLEEVE || (1) TROCAR 12MM BLADELE WITH STAB SLEEVE || (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • Modelo / Serial
    Product code 900-2259A, 3 lots 140312025 140412651 140612902
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿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
    LAPAROSCOPY COLORECTAL SURGICAL PACK || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 26ml LIF || (4) DRAPE UTILITY WITH TAPE LIF || (3) TOWELS ABSORBENT 15" X 20" LIF || (2) LEGGINS W/7'' CUFF 30" X 42" LIF || (1) BLADE SURGICAL# 15 STAINLESS STEEL || (1) BLADE SURGICAL# 11 STAINLESS STEEL || (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF || (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (2) UTILITY BOWL 16oz. LIF || (2) PK. STERI STRIP CLOSURE%'' X 4" L/F || (1) ACTIFOG WITH FOAM PAD SOLUTION LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) NEEDLE ULTRA VERES 120MM LIF || (1) STAPLE ARTICULATING ECHEL 60MM LIF || (1) RELOAD WHITE 60MM ECHELON L/F || (2) CANNULA 5MM XCEL SLEEVES LIF || (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF || (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF || (10) LAP SPONGES PREWASH 18" X 18" XRD LIF || (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF || (2) LITE GLOVE || (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF || (1) ELECTRODE DUAL DEPRES || (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES || (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF || (1) BAG SUTURE FLORAL || (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF || (1) POLISHER CAUTERY TIP LIF || (1) BAG GLASSINE || (1) RELOAD BLUE 60MM LIF || (1) TIME OUT BEACON NON WOVEN LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • Modelo / Serial
    Product code 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿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
    CENTRAL LINE FULL BODY DRAPE || CUSTOMED || CONTENTS: || (1) WRAPPER 30" X 30" || (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg || (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" || (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS || (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • Modelo / Serial
    Product code 900-2270,1 lot 112125073
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿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
    LAPAROSCOPY CHOLE SYSTEM PACK || MIAMI METRO || CON TENTS: || (12) TOWELS CLOTH HUCK BLUE LIF || (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF || (1) BLADE SURGICAL #10 STAINLESS STEEL || (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN || (1) CAUTERY TIP POLISHER LIF || (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF || (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM || (1) TIME OUT BEACON NON WOVEN LIF || (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF || (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF || (1) BLADE SURGICAL #11 CARBON STEEL || (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF || ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • Modelo / Serial
    Product code 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727
  • 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
    LUMBAR PACK || ADVANCED AMBULATORY SURGICAL CENTER || CONTENTS: || (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17" X 23" UF || (1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30" X 30" WITH RUBBER BAND UF (1) DRAPE CHEST 100" X 142" X 72" (1) RULER FLEXIBLE PLASTIC || (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60" X 77" DRAPE REINFORCED UF || (1) STRIP STERI CLOSURE%'' X 4" UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF || (1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8" X 3" NON ADH UF || (1) DRESSING TEGADERM 4 X 4%" UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
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