Device Recall Customed

  • Modèle / numéro de série
    Product code 900-345, 38 lots: 109122917 110020470 110030770 110040936 110071690 110092240 110112640 111010116 111030655 111051294 111051326 111071845 111082215 111092537 111102740 111113101 111123239 112010162 112030866 112051977 112093937 112104306 112124703 112124858 113025959 113036353 113046956 113067922 113088810 113089162 113109830 131210950 140211466 140312155 140412559 140513144 140513338 140613746
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    BASIC PACK W/OUT GOWN- || (1) TABLE COVER REINFORCED 50" X 90" UF || (4) DRAPE UTILITY WITH TAPE UF || (1) TOWEL ABSORBENT 15" x 20" L/F || (1) SUTURE BAG FLORAL || (1) DRAPE SHEET 42" X 57" SMS || g~ SHEET o/. 57" X 63" REINFORCED SMS UF || MAYO STAND COVER REINFORCED UF || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Société-mère du fabricant (2017)
  • Source
    USFDA

331 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Product code 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code 900-2259A, 3 lots 140312025 140412651 140612902
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code 900-2270,1 lot 112125073
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Product code 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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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