Device Recall Customed

  • 모델명 / 제조번호(시리얼번호)
    900-3118; 2 lots: 131210806 140111440
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Breast Pack- FJG, code 900-3118, contains: || (2) GOWN LARGE STANDARD SMS AAMIIII || (2) TOWEL ABSORBENT 15" X 20" || (1) PENCIL CAUTERY PUSH BOTTOM || (1) SYRINGE BULB 60CC || (1) TUBE SUCTION CONNECT~" X 12' || (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG || (1) BOWL UTIL TIY QUART 32oz || (1) COVER MAYO STAND REINFORCED || (2) SKIN MARKER WITH RULER || (2) RULER || (1) COVER TABLE REINFORCED 50" X 90" || (2) CUP DENTURE 8oz TEAL WITH LID || (6) TOWEL CLOTH HUCK BLUE || (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK || (1) YANKAUER SUCTION TUBE WITHOUT VENT || (1) DRAPE BREAST/CHEST SMS || (10) SPONGE LAP PREWASH 18" X 18" XRD || (1) SHEET% DRAPE REINFORCED 60" X 77" || (4) DRAPE UTILITY WITH TAPE || (1) BLADE SURG. #15 CARBON STEEL || (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE || (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE || (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE || (10) GAUZE SPONGE 4" X 4" 16PLY || (1) PK. STRIP STERI CLOSURE W' X 4" || (1) NEEDLE SPINAL ANESTH 22G X 3Y2 || (1) NEEDLE HYPODERMIC 22G X 1Y2 || (1) IV PRIMARY ADD ADMINISTRAT SET || (1) STOPCOCK 3WAY WSWIVEL MALE || (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 331 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Product code 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Product code 900-2259A, 3 lots 140312025 140412651 140612902
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Product code 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Product code 900-2270,1 lot 112125073
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Product code 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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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