Devices

Device Recall Customed

  • Model / Serial
    Code 900-3025, 1 lot: 131110114
  • 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
    Chole Cystectomy All Endo System , code 900-3025, contains: || (1) TABLE COVER 44X 90 UF || (1) SYRINGE 20ccW/O NDL LUER LOCK LIF || (2) MAYO STAND COVER REINFORCED UF || (1) NEEDLE HYPODERMIC || (6) ABSORBENT TOWEL 15 X 20 UF || (1) NEEDLE HYPODERMIC 22G X 1Y. UF || (4) UTILITY DRAPE WIT APE UF || (1) TROCAR DILATING XCELL 5MM X 100 || (3) GOWN XL SURGICAL MICROCOOL L/F || (1) TROCAR ENDOPATH XCEL DILATING TIP || (1) WRAPPER 24" X 24" UF || (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF || (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF || (5) APPLICATOR COTTON 6 WOOD UF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) APPLIER MUL Tl CLIP W/SHAF GUN || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF || (2) DRAPE :Y. ECONOMY 53" X 77" UF || (2) UTLITY BOWL 16oz. UF || (1) SCALPEL WEIGHTED SAFETY #11 UF || (1) RING BASIN || (1) TIME OUT BEACON NON WOVEN UF || (1) TUBE SUCTION CONNECT || (1) MERLING SKIN PREP APPLIC 39ML UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF || (2) TOWEL CLOTH HUCK (BLUE) UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y UF || (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM || (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF || (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM || (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF || (2) LIGHT SHIELD UF || (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 || (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 || (1) PK. STERI STRIP CLOSURE || (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF || (1) MAYO TRAY SMALL || (1) SYRINGE 30ML SLIP TIP 1 ML UF || 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: 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
Device Recall Customed
  • Model / Serial
    LOTS: SL15180 (150619409) 31-MAY-16 SL15181 (150619409) 31-MAY-16 SL15197 (150719607) 31-MAY-16 SL15201-01 (150719607) 31-MAY-16 SL15230 (150820136) 31-AUG-16 SL15251 (150820136) 31-AUG-16 SL15265 (150920652) 30-SEP-16 SL15266 (150920652) 30-SEP-16
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE || 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: SL15194 (150719926) 31-JUL-16 SL15194 (150719927) 31-JUL-16 SL15195-02 (150719927) 31-JUL-16 SL15195-02 (150719926) 31-JUL-16 SL15258 (150719926) 31-JUL-16 SL15258 (150719927) 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: 900028 LAPAROSCOPY SURGICAL PACK
  • Manufacturer
    Customed, Inc
Device Recall Customed
  • Model / Serial
    LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-16
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY || 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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