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-2375-2014
  • 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=129269
  • 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
    Neurological tray - Product Code OJG
  • 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 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475
  • Product Classification
    Neurological 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
    NEURO PACK - || (1) CAUTERY TIP POLISHER LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) INSTRUMENT POUCH || (10) LAP SPONGE PRE-WASH XRD || (1) Pk. SURGICAL STRIP W' X 6" || (2) UTILITY BOWL 32oz || (1) MAYO TRAY LARGE || (9) SHEET DRAPE 41 " X 69" MEDIUM LIF || (1) NEEDLE HYPODERMIC 18G X 1 LIF || (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (2) Pr. SURGICAL GLOVES 7 Y2 || (2) Pr. SURGICAL GLOVES 8 || (2) EAR ULCER SYRINGE 2oz LIF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) SHEET MINOR LAP 102" X 121" X 78" || (1) SAFETY SCALPEL #10 || (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF || (4) CLOTH HUCK TOWELS BLUE || (1) PENCIL CAUTERY ROCKER SWITCH || (2) LEGGINS W/7'' CUFF 30" X 42" || (1) DRAPE% ECONOMY 53" X 77" LIF || (1) Pk. SURGICAL STRIP 'X" X 6" || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F || (2) ROUND WASH BASIN 6QT || (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE || (2) Pr. SURGICAL GLOVES 7 || (1) SKIN MARKER WITH RULER LIF || (1) Pk. STERI STRIP CLOSURE %"X 4" LIF || (1) TUBE SUCTION CONNECT. 'X" X 12' LIF || (1) SAFETY SCALPEL #15 || (1) SAFETY SCALPEL #11L/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