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-2382-2014
  • 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=129276
  • 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
    Cesarean section kit - Product Code OHM
  • 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 900-1294, 18 lots: 111030560 111030815 112020527 112114630 112124933 113015688 113026042 113036408 113057858 113089182 113109717 131110166 131210694 140211638 140312063 140412594 140513078 140513477
  • 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
    PREMIUM CESAREAN PACK- CUSTOMED- || (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT || (3) TOWELS ABSORBENT 15" X 20" LIF || (1) BOWL PLASTIC 80oz WITH LID || (10) LAP SPONGE PREWASH XRD LIF || (2) PAD OBSTETRICAL X-LARGE ST. || (1) MAYO STAND COVER REINFORCED LIF || (1) DRAPE SHEET 41 " X 58" SMS LIF || (1) TUBE SUCTION CONNECT. X" X 12' LIF || (1) EAR ULCER SYRINGE 2oz LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) CORD UMBILICAL CLAMP LIF || (1) DRESSING ISLAND 4" X 10" || (1) BLADE SURGICAL#10 CARBON STEEL || (1) BLADE SURGICAL#20 CARBON STEEL || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) C-SECTION DRAPE WITH POUCH || (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III || (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP || 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