Devices

Device Recall Customed

  • Model / Serial
    Product code 900-996, 34 lots: 111040982 111051305 111061694 111071947 111082120 111092410 111092465 111102789 111113147 111123308 112010213 112020496 112030757 112041365 112052027 112072880 112083444 112093958 112114585 112125124 113025974 113036393 113057517 113057612 113057822 113078480 113078577 113099300 113099581 131110081 131110607 140111262 140211738 140513485
  • Product Classification
    Gastroenterology-Urology 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
    LAPAROTOMY PACK- || (1) MAYO STAND COVER REINFORCED LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (5) LAP SPONGES PRE-WASH 18" X 18" XRD LIF || (1) LITE GLOVE LIF || (1) BAG SUTURE FLORAL || (1) BLADE SURGICAL #1 0 CARBON STEEL || (1) BLADE SURGICAL #15 CARBON STEEL || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) CAUTERY TIP POLISHER LIF || (1) BAG GLASSINE || (1) TABLE COVER 44" X 90" L/F || (2) DRAPE SHEET 41 " X 58" SMS || (1) LAPAROTOMY DRAPE "T" 102" X 78" X 121" STD SMS || (4) DRAPE UTILITY WITH TAPE LIF || (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF || (1) TUBE SUCTION CONECT W' X 12' LIF || (3) ABSORBENT TOWELS 15" X 20" LIF || (1) CAUTERY PENCIL PUSH BOTTON || (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP LEVEL Ill || (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF || 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: SL15202 (150719846) 31-JUL-16 SL15203 (150719846) 31-JUL-16 SL15229 (150820299) 31-AUG-16 SL15231 (150820299) 31-AUG-16
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 9002609 || ARTHOSCOPY 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: SL15212 (150719962) 31-JUL-16 SL15274 (150920990) 30-JUN-16 SL15274 (150920989) 30-SEP-16
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 9002614 || HIP AND KNEE REPLACEMENT 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: SL15181 (150619402) 30-JUN-16 SL15184 (150619402) 30-JUN-16 SL15184 (150619265) 30-JUN-16 SL15274 (150820300) 30-SEP-16 SL15275 (150820301) 30-SEP-16 SL15275 (150820300) 30-SEP-16
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 9002615 || EXTREMITY 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: SL15177 (150619477) 30-JUN-16 SL15181 (150619477) 30-JUN-16 SL15212 (150719843) 31-JUL-16 SL15215 (150719843) 31-JUL-16 SL15219 (150719843) 31-JUL-16 SL15271 (150920812) 30-SEP-16
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 9002618 || OPEN HEART 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: SL15201-02 (150619403) 31-JUL-16 SL15201-02 (150619266) 31-JUL-16 SL15202 (150619403) 31-JUL-16 SL15208 (150619403) 31-JUL-16 SL15232 (150820302) 31-AUG-16 SL15243 (150820302) 31-AUG-16 SL15246 (150820303) 31-AUG-16 SL15251 (150820303) 31-AUG-16
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed only in Puerto Rico.
  • Product Description
    Catalog Number: 9002726 || HIP AND KNEE REPLACEMENT 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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