Devices

Device Recall Customed

  • Model / Serial
    Product code 900-921A, 4 lots: 140312028 140412706 140513148 140513469
  • Product Classification
    Obstetrical and Gynecological 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
    C-SECTION SURGICAL PACK- || (1) COVER TABLE REINFORCED 50" X 90" || (2) TOWELS ABSORBENT 15" X 20" || (1) MAYO STAND COVER REINFORCED || (1) BABY BLANKET PRINTED || (1 0) LAP SPONGES PREWASH 18" X 18" XRD || (1) BOWL PLASTIC WITH LID 80oz. || (1) BAG GLASSINE || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR || (1) CORD UMBILICAL CLAMP || (2) LIGHT GLOVE || (1) BOWL UTILITY 32oz || (1) BOWL UTILITY 16oz || (4) DRAPE UTILITY || (1) TUBE SUCTION CONNECT. 1!4" X 12' || (1) TIP CAUTERY POLISHER || (1) MUCUSTRAP 20cc, 10FR. || (2) DRAPE SHEET 41" X 58" SMS || (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE || (1) PENCIL CAUTERY ROCKER SWITCH || (1) ELECTRODE DUAL DEPRES./GROUNDPAD || (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" || (1) EAR ULCER SYRINGE 2oz || (1) BABY BEANNIES || (1) RECEIVING BLANKET 100% COTTON || (2) SURGICAL BLADE #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: SL15169 (150619380) 30-JUN-16 SL15174 (150619380) 30-JUN-16 SL15201-01 (150719634) 31-JUL-16 SL15212 (150720070) 31-JUL-16 SL15212 (150720071) 31-JUL-16 SL15272 (150920769) 30-SEP-16 SL15273 (150920769) 30-SEP-16
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 9001297 || PREMIUM OBSTETRICAL 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
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