Devices

Device Recall Customed

  • Model / Serial
    Product code 900-741, 16 lots: 112041352 112072877 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
    IMPLANTE DE ORTHOPEDIA- || 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF || (1) DURAPREP SURGICAL SOLUTION 26ml LIF || (1) BAG SUTURE FLORAL LIF || (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F || (1) CAUTERY PENCIL ROCKER SWITCH LIF || (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX || (2) BLADE SURGICAL# 10 STAINLESS STEEL || (1) BAG GLASSINE || (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF || (2) LITE GLOVE LIF || (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF || (1) MAYO STAND COVER REINFORCED LIF || (4) DRAPE UTILITY WITH TAPE LIF || (5) ABSORBENT TOWELS 15" X 20" LIF || (5) LAP SPONGES PRE-WASH XRD LIF || (2) DRAPE SHEET 70" X 100" STD SMS LIF || (1) MAYO TRAY LARGE || (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX || (1) STAPLE SKIN WIDE 35 ST. LIF || (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF || (1) BULB SYRINGE 60cc || (2) BANDAGE ELASTIC 6" X 5"yds LIF || (2) UTILITY BOWL 32oz || (1) UTILITY BOWL 16oz LIF || (1) SKIN MARKER WITH RULER || (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF || (2) ABDOMINAL PAD 8" X 7 W || (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' || (2) GOWN IMPERVIOUS REINFORCED XL || (1) YANKAUER SUCTION TUBE WITHOUT VENT UF || (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE || 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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