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-2444-2014
  • 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=129402
  • 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
    laparoscopy kit - Product Code FDE
  • 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 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501
  • Product Classification
    Gastroenterology-Urology 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
    LAPAROSCOPIA COLORECTAL PACK || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 26ml || (4) DRAPE UTILITY WITH TAPE || (1) TOWELS ABSORBENT 15" X 20" || (2) LEGGINS W/7" CUFF 30" X 42" || (1) BLADE SURGICAL #15 STAINLESS STEEL || (1) BLADE SURGICAL #11 STAINLESS STEEL || (1) GOWN IMPERV. EXTRA REINFORCED XLG || (1) GOWN LGE STANDARD SMS VELCRO NECK || (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (2) UTILITY BOWL 16oz || (2) STERI STRIP CLOSURE W' X 4" || (1) ACTIFOG W/FOAM PAD SOLUTION || (1) TABLE COVER REINFORCED 50" X 90" || (1) MAYO STAND COVER REINFORCED || (1) NEEDLE ULTRA VERES 120MM || (1) STAPLE ARTICULATING ECHEL 60MM || (1) RELOAD WHITE 60MM ECHELON || (1) RELOAD BLUE 60MM ECHELON || (2) CANNULA 5MM XCEL SLEEVES || (1) TROCAR 5MM BLADELE WITH STAB SLEEVE || (1) TROCAR 12MM BLADELE WITH STAB SLEEVE || (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS || Product Usage: || 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