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-2369-2014
  • 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=129263
  • 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 900-1059, 16 lots: 112030823 113047111 113057410 113057823 113078454 113078566 113099561 113109983 131110149 131110397 131110577 131210955 140211914 140312430 140513062 140513474
  • 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
    LAPAROSCOPY CHOLE PACK - || (4) DRAPE UTILITY WITH TAPE LIF || (2) ABSORBENT TOWELS 15" X 20" LIF || (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF || (1) SURGICAL DURAPREP SOLUTION 26ml LIF || (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. || (1) DRAPE LASER CAMERA W/EL 6" X 96" || (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F || (1) TABLE COVER 44" X 90" || (1) MAYO STAND REINFORCED L/F || (1) SURGICAL BLADE # 11 CARBON STEEL || (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF || (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F || (1) TUBE SUCTION CONNECTING W' X 12' LIF || (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF || (1) CEF AZOLIN RED LABEL || (1) GENTAMICIN GREEN LABEL || (1) AZUL DE METILENO LABEL || (1) HEPARINE WHITE LABEL || (1) LIDOCAINE YELLOW LABEL || 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