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-2356-2014
  • 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=129250
  • 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • 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 900-902, 11 lots: 112041360 112051755 112052021 113015521 113025983 113036389 113067942 113078352 140312189 140412917 140513342
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • 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
    ARTHROSCOPY PACK- || (2) ABSORBENT TOWELS 15" x 20" LIF || (1) TUBE SUCTION CONNECT Y.." X 12' LIF || (1) ELASTIC BANDAGE 6" X 5yrd. UF || (1) IMPERVIOUS STOCKINETTE 14" X 48" || (1) HUCK CLOTH TOWEL WHITE || (1) MAYO STAND COVER REINFORCED LIF || (1) U DRAPE 60" X70" WITH TAPE SPLIT || (4) STRIPS TAPE 24" X 4" L/F || (1) STOCKINETTE 6" X 48" LIF || (1) MAYO TRAY SMALL || (5) HUCK CLOTH TOWELS BLUE || (2) UTILITY BOWL 32oz || (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV || (1) SOLUTION SURGICAL DURAPREP 26ml UF || (1) SHEET EXTREMITY ABS. 125" x 85" SMS || (5) LAP SPONGE PREWASH XRD || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) PENCIL CAUTERY ROCKER SWITCH || (1) SKIN MARKER INK WITH 8 LABEL || (2) LITES GLOVES UF || (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR || (1) CAUTERY TIP POLISHER UF || (4) DRAPE UTILITY WITH TAPE UF || (1) BAG BIOHAZARD 30" X 37" || (1) BAG SUTURE FLORAL || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF || (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP || 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