Events

Recall of Device Recall Customed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Customed, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68536
  • Event Risk Class
    Class 1
  • Event Number
    Z-2311-2014
  • Event Initiated Date
    2014-05-20
  • Event Date Posted
    2014-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129144
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • Reason
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Action
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

Device Recall Customed
  • Model / Serial
    Product code 900-170, 45 lots: 110102563 110112615 110123042 111010248 111020273 111041096 111051368 111061709 111071957 111082061 111082257 111092361 111092454 111102694 112010081 112020399 112030637 112041196 112051864 112062443 112072782 112093724 112125027 113015544 113025946 113026104 113036753 113047198 113057812 113068156 113078518 113088755 113089018 113089196 113099566 131110068 131110400 131110579 131210963 140111411 140211740 140312329 140412793 140513106 140513245
  • Product Classification
    Cardiovascular 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
    OPEN HEART TRAY - PACK- || (25) SPONGE LAP PREWASH 18" X 18" XRD L/F || (1) TRAY PLATO LARGE || (3) DRESSING NON ADH TELFA 8 X 3 || (2) BAG GLASSINE PLAIN || (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) COVER TABLE REINFORCED 50" X 90" LIF || (1) NEEDLE HYPODERMIC 27G X 'h" || (4) COUNTER NEEDLE & BLADE 10c MAG/CLEAR || (2) SYRINGE 20cc WITHOUT NDL LUER LOCK LIF || (1) JAR 16oz 500cc GRADUATE MEASURE || (2) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F || (2) PENCIL CAUTERY HAND SWITCHING LIF || (1) MARKER SKIN RULER || (2) BANDAGE ELASTIC 4" X 5yds LIF || (2) POLISHER CAUTERY TIP LIF || (2) BANDAGE ELASTIC 6" X 5yds LIF || (2) SYRINGE BULB 60cc CLEAR || (2) TUBE SUCTION CONNECT Y-t'' X 12' LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (1) NEEDLE BLADE/KNIFE 3.0mm || (2) CONTAINER SPECIMEN 40z. WITH LID & LABEL || (1) BLADE SHARP ALL ARROUND || (1) BASIN EMESIS 10 IN 700cc || (3) CATHETER 20FR ROB NEL RED RUB || (3) BOWL UTILITY QUART 32oz LIF || (2) CATHETER THORACIC 32FR STRAIGH || (1) LABELS SET, HEPARINE, SALINE, ETC. || (2) SAFETY SCALPEL #10 DISP || (3) BASIN WASH ROUND 6QT (2) SAFETY SCALPEL #15 DISP || (2) BOWL UTILITY 16oz L/F || (1) WRAPPER 54" X 54" L/F || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Manufacturer Address
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
    Customed Inc
  • Source
    USFDA