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-2424-2014
  • 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=129318
  • 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 900-1967, 19 lots: 111123453 112030696 112041219 112041457 112051908 112062470 112083417 112125164 113015692 113025952 113026107 113026233 113047010 113057694 113078292 140211807 140312103 140412626 140412893
  • 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) APPLIER MULTI CLIP WITH SHAF GUN L/F || ( 1) NEEDLE ULTRA VERES 120MM LIF || ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF || ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF || (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III || (1) MAYO STAND COVER REINFORCED LIF || (5) SPONGE LAP PREWASH 18" X 18" XRD LIF || ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF || ( 1) BOWL UTILITY 16oz. LIF || (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF || (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (4) DRAPE UTILITY WITH TAPE LIF || (4) TOWELS ABSORBENT 15" X 20" LIF || (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F || (2) SHEET DRAPE 42" X 57" SMS LIF || (1) BLADE SURGICAL #11 STAINLESS STEEL || ( 1) TIME OUT BEACON NON WOVEN ST L/F || (6) GAUZE SPONGE 2" X 2" 4PL Y LIF || ( 1) BLADE SURG. #15 CARBON STEEL || ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF || (1) TABLE COVER REINFORCED 50" X 90" L/F || Product Usage: || 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