Devices

Device Recall Customed

  • Model / Serial
    Code 900-2829, 4 lots 140111331 140211831 140312145 140412671
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • 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
    LAPAROTOMY PACK BASIC || CODE 900-2829 || CONTENTS: || (2) TOWELS ABSORBENT 15" X 20" || (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE || (1) BAG SUTURE FLORAL || (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS || (1) COVER TABLE REINFORCED 50" X 90" || (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill || (1) TIME OUT BEACON NON WOVEN || (1) COUNTER NDUBLADE 20C FOAM/MAG || (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill || 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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