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-2321-2014
  • 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=129159
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Ring, laparotomy - Product Code PHI
  • 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 900-404, 35 lots: 102030840 111030924 111041044 111051296 111061668 111123243 112010164 112020524 112041317 112041373 112041448 112062487 112083429 112114599 112125087 112125314 113025961 113036355 113036763 113047220 113057480 113057846 113068046 113078323 113078574 113089071 113099290 113099572 131110410 131110587 131210971 140111452 140211742 140412837 140513247
  • 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
    MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD || (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz || (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER || (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE || (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED || (4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS || (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED || (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN || (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER || 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