Devices

Device Recall Customed

  • Model / Serial
    Product code 900-1933, 20 lots: 112114613 112125046 113015506 113025815 113036476 113046936 113047008 113057440 113057613 113057842 113078288 113078581 113089021 113099282 113109641 131110072 131110603 131210966 140412831 140513465
  • Product Classification
    Ophthalmic 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
    OPHTALMIC PACK- || (1) TABLE COVER REINF. 44" X 78" UF || (1) GOWN SMS XLGE STD UF || (2) TOWEL ABSORBENT 15" X 20" LIF || (1) SYRINGE 3cc W/0 NDL LILOCK UF || (1) MAYO STAND COVER REINF. LIF || (1) NEEDLE HYPODERMIC 18G X 1% ST. UF || (10) EYE MICRO SPONGE UF || (2) LABEL CONTRAST BLUE || (1) GOWN LGE STD SMS || (1) WIPE INSTRUMENT 1MM || (1) EYE DRAPE UF || (1) LABEL XYLOCAINE FOR MEDICATION YELLOW || (1) IODINE POVIDONE 1oz. || (1) EYE SHIELD UNIVERSAL L/F || (10) APPLICATOR COTION 6" WOOD || (1) BALANCED SALT SOLUTION 18ML LIF || (10) GAUZE SPONGE 4" X 4" 12P Y UF || (1) LABEL BSS || (1) TRAY 3/COMPARTMENT LIF || (1) LABEL EPINEPHRINE VIOLET/WHITE || (1) LABEL IODINE WHITE/BLACK || 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: 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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