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-2327-2014
  • 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=129178
  • 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
    laparoscopy kit - Product Code FDE
  • 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 900-474, 19 lots: 112030843 112103944 112114393 112114480 112125096 113015452 113036801 113057847 113078330 113088867 113089075 113109844 131110262 131210818 140111232 140211671 140412469 140412888 140513480
  • Product Classification
    Gastroenterology-Urology 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
    LAPAROSCOPY PACK- - || (1) DRAPE LAP ABDOMINAL WITH POUCH || (1) CAMARA DRAPE 9" X 96" LIF || (5) TOWELS ABSORBENT 15" X 20" || (1) MAYO STAND COVER REINFORCED || (1) TABLE COVER REINFORCED 50" X 90" || (4) DRAPE UTILITY WITH TAPE || (3) DRAPE SHEET 41" X 58" SMS || (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR || (5) LAP SPONGE PREWASH 18" X 18" XRD || (1) GOWN LGE SMS IMPERVIOUS REINFORCED || (2) GOWN X-LARGE SMS IMPERV. REINFORCED || (2) MEDICINE CUP 2oz. || (1) NEEDLE HYPODERMIC 18G X 1% ST. || ( 1) BLADE SURG. # 15 CARBON STEEL || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK || (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR || (1) DRESSING TEGADERM 4" X 4%" || (1) SOLUTION SURGICAL DURAPREP 6mL || (1) TRAY MAYO SMALL || (1) TUBE SUCTION CONNECT. %"X 12' || (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (1) NEEDLE ECLIPSE 22 X 1% || (1) TIME OUT BEACON NON WOVEN ST || 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