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-2517-2014
  • 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=129557
  • 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
    Code 900-3025, 1 lot: 131110114
  • 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
    Chole Cystectomy All Endo System , code 900-3025, contains: || (1) TABLE COVER 44X 90 UF || (1) SYRINGE 20ccW/O NDL LUER LOCK LIF || (2) MAYO STAND COVER REINFORCED UF || (1) NEEDLE HYPODERMIC || (6) ABSORBENT TOWEL 15 X 20 UF || (1) NEEDLE HYPODERMIC 22G X 1Y. UF || (4) UTILITY DRAPE WIT APE UF || (1) TROCAR DILATING XCELL 5MM X 100 || (3) GOWN XL SURGICAL MICROCOOL L/F || (1) TROCAR ENDOPATH XCEL DILATING TIP || (1) WRAPPER 24" X 24" UF || (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF || (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF || (5) APPLICATOR COTTON 6 WOOD UF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) APPLIER MUL Tl CLIP W/SHAF GUN || (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF || (2) DRAPE :Y. ECONOMY 53" X 77" UF || (2) UTLITY BOWL 16oz. UF || (1) SCALPEL WEIGHTED SAFETY #11 UF || (1) RING BASIN || (1) TIME OUT BEACON NON WOVEN UF || (1) TUBE SUCTION CONNECT || (1) MERLING SKIN PREP APPLIC 39ML UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF || (2) TOWEL CLOTH HUCK (BLUE) UF || (1 0) GAUZE SPONGE 4 X 4 16PL Y UF || (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM || (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF || (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM || (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF || (2) LIGHT SHIELD UF || (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 || (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 || (1) PK. STERI STRIP CLOSURE || (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF || (1) MAYO TRAY SMALL || (1) SYRINGE 30ML SLIP TIP 1 ML UF || 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