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-2402-2014
  • 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=129296
  • 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
    General surgery tray (kit) - Product Code LRO
  • 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 900-1587, 36 lots: 102030623 110082155 110082298 110102430 110112610 110122922 111010202 111020362 111030586 111040993 111051366 111061501 111071771 111082193 111092502 111102687 111113016 111123356 112010065 112020382 112041190 112051845 112062430 112072709 112083158 112083400 113015504 113025773 113036453 113036751 113067890 113089195 113099383 131110184 140111159 140312077
  • Product Classification
    General and Plastic Surgery 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
    UNIVERSAL PACK - || (1) TRAY ORGANIZER FULL DEEP || (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF || (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF || (1) NEEDLE HYPODERMIC 20G X 1 ~ UF || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill || (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF || (1) SHEET% 57" X 63" REINFORCED SMS LIF || (2) TOWELS ABSORBENT 15" X 20" LIF || (4) DRAPE UTILITY LIF || (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF || (4) CLOTH HUCK TOWELS BLUE LIF || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) SCALPEL WITH HANDLE #11 || (1) DENTURE CUP WITH LID || (1) TRAY 2 COMPARTMENT || (2) ABSORBENT TIP APPLICATOR || (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF || (1) TAPE TRANSPORE 1" X 36" || (1) DIISP NEEDLE 30 X ~ || (1) PROBE DRAPE 6" X 96 WITH GEL || (1) ARTERIAL NEEDLE 18 X 2 % || (1) CATHETER INTRODUCER 7FR || (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR 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