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-2324-2014
  • 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=129162
  • 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 900-419, 16 lots: 112041449 112093941 112114601 113025847 113026169 113036364 113047313 113067871 113078327 113089073 113099292 131110077 131210815 140111228 140211670 140311939
  • 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
    LABOR & DELIVERY PAC - || 1) NEEDLE HYPODERMIC 18G X 1% ST. || (2) DRAPE UNDERBUTTOCK WITH POUCH || (4) TOWELS ABSORBENT 15" X 20" || ( 1) FEEDING TUBE 8FR, 15" LONG || ( 1) BEANNIES BABY || ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK || ( 1) UMBILICAL CORD CLAMP ST. || ( 1) RECEIVING BLANKET 100% COTTON || ( 1) TOWELS CLOTH HUCK (BLUE) || (2) LEGGINGS W/7" CUFF 30" X 42" || ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. || ( 1) BOWL PLASTIC 80oz || ( 1) LID FOR BOWL 80oz CLEAR || (20) GAUZE SPONGE 4" X 4" 16PLY || (2) PAD OBSTETRICAL X-LARGE ST. || ( 1) PACKING VAGINAL XRD 4 X 36 8PLY || ( 1) TABLE COVER REINFORCED 50" X 90" || ( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54" || (1 ) NEEDLE HYPODERMIC 21G X 1% ST. || (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK || (2) PVP SCRUB 8" STICK SPONGES ST. || ( 1) EAR ULCER SYRINGE 2oz. || ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED || (2) WRAPPER 30" X 30" || ( 1) PVP PAINT 8" STICK SPONGE ST. || (2) GLOVE SURG DERMA PRENE #7 % PF || (1) TIME OUT BEACON NON WOVEN ST. || (1) VACUTAINER GREEN NAHEP 10ML || 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