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-2314-2014
  • 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=129148
  • 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
    Obstetrical kit - Product Code OKV
  • 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 900-254, 22 lots: 111113093 111123230 112030815 112041318 112051972 112093935 112114665 113026059 113026113 113036348 113036461 113047019 113047218 113057472 113088799 113089161 113109797 131110249 131210793 140312134 140412465 140412904
  • Product Classification
    Obstetrical and Gynecological 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
    0.B. PACK - HSCH- || (1) PVP SCRUB 8" STICK SPONGES || (1) UNDERBUTTOCK DRAPE WITH POUCH || (2) LEGGINS WITH 7" CUFF 30" X 42" || (1) ABDOMINAL DRAPE WITH TAPE LIF || (1) SPONGE LAP PREWASH 18" X 18" XRD LIF || (1) BOWL PLASTIC WITH LID 80oz LIF || (1) RECEIVING BLANKET 100% COTTON || (1) BABY BLANKET IMPERVIOUS POLY ABS. LIF || (1) UMBILICAL CORD CLAMP || (3) ABSORBENT TOWELS 15" X 20" LIF || (1) UTILITY BOWL 16oz LIF || (2) TRAY ORGANIZER FULL DEEP || (3) ABSORBENT TIP APPLICATOR || (2) GLOVE EXAM MEDIUM || (1) GOWN SURGICAL REINFORCED LARGE TOWEL/WRAP || (10) GAUZE SPONGE 4" X 4" 12PLY || (2) PAD OBSTETRICAL X-LARGE ST. LIF || (1) EAR ULCER SYRINGE 2oz UF || (1) BABY BEANNIES || (2) DRAPE SHEET 41 " X 58" SMS || (1) SCISSORS UMBILICAL || (1) TABLE COVER REINFORCED 44" X 78" L/F || (2) WRAPPER 24" X 24" LI || 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