Devices

Device Recall Customed

  • Model / Serial
    Code 900-2918, 8 lots 113047023 113057703 113068037 113078429 113078733 113109799 140312147 140613795
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    TLIF PACK || SURGICAL CENTER, CODE 900-2918. || CONTENTS: || (2) SOLUTION SURGICAL DURAPREP 26ML UF || (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF || (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF || (4) TOWELS ABSORBEN 15" X 20" LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED LIF || (4) DRAPE% 60" X 76" REINFORCED L/F || (1) DRAPE CHEST 100" X 142" X 72" LIF || (1) FLUORO COVER 30" X 30" WITH RUBBBAND LIF || (2) LITE GLOVE LIF || (2) TUBE SUCTION CONNECT. Y." X 12' UF || (12) TOWELS CLOTH HUCK BLUE LIF || (1) UTILITY BOWL QUART 32oz || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) CAUTERY PENCIL ROCKER SWITCH WITH HOLSTER LIF || (1) STERI STRIP DRAPE LARGE 17" X 23" LIF || (1) SKIN MARKER WITH RULER UF || (9) LABELS FOR SKIN MARKERS 1.25 X Y2 || (1) RULER || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG L/F || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) BULB SYRINGE 60cc LIF || (4) NEEDLE HYPODERMIC 18G X 1Y2 UF || (1) NEEDLE HYPODERMIC 22G X 1Y2 LIF || (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK UF || (1) NEEDLE SPINAL 18G X 6" LONG LENGTH LIF || (1) BLADE SURGICAL # 10 CARBON STEEL || (1) BLADE SURGICAL # 15 CARBON STEEL || (1) TIME OUT BEACON NON WOVEN UF || (2) DRESSING TEGADERM 4" X 4% "UF || (2) MEDICINE CUP 2oz || (1) DRAPE IOBAN INCISE 2 ANTIMICROBIAL 23" X 23" LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer
    Customed, Inc
  • 1 Event

Manufacturer

Customed, Inc
  • Manufacturer Address
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
    Customed Inc
  • Source
    USFDA

331 devices with a similar name

Learn more about the data here

Device Recall Customed
  • Model / 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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
    Customed, Inc
Device Recall Customed
  • Model / Serial
    LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
    Customed, Inc
Device Recall Customed
  • Model / Serial
    LOT: SL15209 (150719960) 31-JUL-16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
    Customed, Inc
Device Recall Customed
  • Model / 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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
    Customed, Inc
Device Recall Customed
  • Model / Serial
    Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    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
    Customed, Inc
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