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-2329-2014
  • 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=129180
  • 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 900-486, 39 lots: 109102328 109112574 109122809 110010090 110020385 110030671 110030811 110051245 110071697 110102446 110112662 111010131 111020373 111030681 111041112 111113120 111123259 111123435 112020536 112030844 112051987 112093629 112114394 112114481 112114571 113015453 113025988 113036367 113057489 113067929 113099436 113109846 131110263 131210820 140111233 140312167 140412470 140412907 140513249
  • 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) MAYO STAND COVER REINFORCED LIF || (2) DRAPE % ECONOMY 53" X 77" LIF || (1) TUBE SUCTION CONNECT. v.i" X 12' LIF || (1) SCALPEL WITH HANDLE #11 || (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF || (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF || (8) TOWEL ABSORBENT 15" X 20" L/F || (1) TABLE COVER REINFORCED 50" X 90" L/F || (1) *LAPAROSCOPIC WOUND CLOSURE LATEX || (1) DRAPE LASER CAMERA WITH/EL 6" X 96" LIF || (4) DRAPE UTILITY WITH TAPE L/F || (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F || 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