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-2396-2014
  • 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=129290
  • 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
    Angiography/angioplasty kit - Product Code OEQ
  • 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 900-1488, 16 lots: 111123348 112010051 112020372 112030619 112041075 112072775 112104146 112124636 112124951 113025839 113026046 113036412 113078257 131210748 140211642 140412601
  • Product Classification
    Cardiovascular 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
    ANGIOGRAPHY PACK - || (1) LINE H.P. 1200 PSI 48" M/F || (1) ANG. FEMORAL DRAPE WITH POUCH UF || (1) PLATFORM TRAY LARGE || (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) BAG BAND RUBBAN & TAPE UF || (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (5) ABSORBENT TOWELS 15" X 20" LIF || (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF || (1) SURGICAL DURAPREP SOLUTION 6ML LIF || (1) SAFETY SCALPEL #11 STAINLESS STEEL || (2) GOWN STANDARD SMS LARGE VELCRO NECK || (1) MANIFOLD WITH CONTROL SYRINGE || (1) NEEDLE 18G X 2% AMC/4 || (2) UTILITY BOWL 16oz UF || (2) CLOTH HUCK TOWEL BLUE || (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF || (2) MEDICINE CUP 2oz LIF || (30) GAUZE SPONGE 4" X 4" 16PL Y || (1) NEEDLE HYPODEMIC 18G X 1 ~ || (4) TOWEL CLAMP || (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF || (1) HALSTED MOSQUITO CVD 5" SERRAT || (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F || (2) NEEDLE HYPODERMIC 22G X 1 || 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