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-2366-2014
  • 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=129260
  • 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 900-998, 30 lots: 110102460 110112688 110123134 111010177 111020380 111040983 111051307 111061695 111071843 111082122 111092412 111092562 111102894 111123312 111123473 112020498 112030759 112041367 112072882 112083446 112093766 112114689 112125126 113026063 113036770 113078482 113109886 140111264 140311950 140412910
  • 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
    C-SECTION PACK - || (1) TABLE COVER REINFORCED 50" X 90" L/F || (3) TOWELS ABSORBENT 15" X 20" L/F || (1) BABY BLANKET || (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV || (2) PAD OBSTETRICAL XL LIF || (1) LITE GLOVE LIF || (1) DRAPE SHEET 41" X 69" MEDIUM LIF || (2) SURGICAL BLADE #10 CARBON STEEL || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF || (1) BAG GLASSINE || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR || (1) CONTAINER 64oz WITH LID || (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF || (1) MAYO STAND COVER REINFORCED UF || (1) BAG SUTURE FLORAL || (15) LAP SPONGES PRE-WASH XRD LIF || (1) EAR ULCER SYRINGE 2oz UF || (1) CORD UMBILICAL CLAMP L/F || (1) WASH BASIN ?QT. || (1) CAUTERY TIP POLISHER LIF || (1) YANKAUER SUCTION TUBE W/0 VENT LIF || (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" || (1) FEEDING TUBE 8FR. 15" LONG || (4) DRAPE UTILITY WITH TAPE UF || (1) TUBE SUCTION CONNECT. Y." X 12' UF || (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV || 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