Devices

Device Recall Customed

  • Model / Serial
    Product code 900-741A, 2 lots: 140412701 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736
  • 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
    ORTHO IMPLANT SURGICAL PACK - || (1) CAUTERY TIP POLISHER || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" || (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" || (1) TUBE SUCTION CONNECT. }4" X 12' || (1) DURAPREP SURGICAL SOLUTION 26ml || (1) BAG GLASSINE || (1) YANKAUER SUCTION TUBE WITHOUT VENT || (2) LITE GLOVE || (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS || (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE || (1) STOCKINETTE IMPERVIOUS 14" X 48" || (1) MAYO STAND COVER REINFORCED || (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" || (5) ABSORBENT TOWELS 15" X 20" || (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV || (4) DRAPE UTILITY || (1) CAUTERY PENCIL ROCKER SWITCH || (5) LAP SPONGES PREWASH XRD || (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE || (2) DRAPE SHEET 70" X 100" STD SMS || (1) TIME OUT BEACON NON WOVEN || (1) STAPLE SKIN WIDE 35 ST. || (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER || (1) MAYO TRAY LARGE || (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG || (1) TOP DRAPE W/ADHES. 100" X 53" SMS || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP || (2) BANDAGE ELASTIC 6" X 5"yds || (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK || (1) UTILITY BOWL 16oz || (1) NEEDLE HYPODERMIC 18G X 1Y2 || (2) UTILITY BOWL 32oz || (2) BLADE SURGICAL# 10 STAINLESS STEEL || 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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