Events

Recall of Amalgatome SD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exsurco Medical.

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
    80300
  • Event Risk Class
    Class 2
  • Event Number
    Z-2291-2018
  • Event Initiated Date
    2018-04-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165083
  • 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
    Dermatome - Product Code GFD
  • Reason
    Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
  • Action
    On April 17, 2018 Exsurco Medical hand delivered notices to customers. Customers were advised to take the following actions: -Review, complete and return the Customer Response Card. -Upon verifying the information, provide the information to all Burn Account Managers. -An Exsurco Field Service Technician will perform the correction. Starting July 1, 2018, Exsurco Medical will issue URGENT Medical Device Recall notices and response cards to Burn Account Managers via certified mail or by hand delivery. Exsurso Medical will also provide replacement hoses simultaneously. Burn Account Managers are advised to take the following actions: -Review, complete and return the Customer Response Card. -Replace all impacted X101004 Pneumatic Hoses with replacement hoses. -Discard impacted X101004 Pneumatic Hoses as outlined in the recall notification. Should you have any questions regarding this matter please contact (440) 204-3239/ email: saigal@exsurco.com.

Device

Amalgatome SD
  • Model / Serial
    Serial Numbers: SDH201607220029 SDH201607220030 SDH201607220031 SDH201607220032 SDH201607220033 SDH201607220034 SDH201607220035 SDH201607220036 SDH201607220037 SDH201607220038 SDH201607220039 SDH201607220040 SDH201607220041 SDH201607220043 SDH201607220044 SDH201607220046 SDH201607220048 SDH201607220049 SDH201607220050 SDH201607220051 SDH201607220052 SDH201607220053 SDH201607220054 SDH201607220055 SDH201607220056 SDH201607220057 SDH201607220058 SDH201607220059 SDH201607220060 SDH201607220061 SDH201607220062 SDH201607220063 SDH201607220064 SDH201607220065 SDH201607220067 SDH201607220068 SDH201607220069 SDH201607220070 SDH201607220071 SDH201607220072 SDH201607220073 SDH201607220075 SDH201607220076 SDH201607220077 SDH201607220078 SDH201607220079 SDH201607220080 SDH201607220081 SDH201607220082 SDH201607220083 SDH201607220084 SDH201607220085 SDH201607220086 SDH201607220087 SDH201607220088 SDH201607220089 SDH201607220090 SDH201607220091 SDH201607220092 SDH201607220093 SDH201607220094 SDH201607220095 SDH201607220096 SDH201607220097 SDH201607220098 SDH201607220099 SDH201607220047 SDH201607220001 SDH201607220002 SDH201607220003 SDH201607220004 SDH201607220005 SDH201607220006 SDH201607220007 SDH201607220008 SDH201607220009 SDH201607220010 SDH201607220011 SDH201607220012 SDH201607220013 SDH201607220014 SDH201607220015 SDH201607220016 SDH201607220017 SDH201607220018 SDH201607220019 SDH201607220020 SDH201607220021 SDH201607220022 SDH201607220023 SDH201607220024 SDH201607220025 SDH201607220026 SDH201607220027 SDH201607220028 SDH201607220042 SDH201607220045 SDH201607220066 SDH201607220074 SDH201804100101 SDH201804100102 SDH201804100103 SDH201804100104 SDH201804100105 SDH201804100106 SDH201804100107 SDH201804100108 SDH201804100109 SDH201804100110 SDH201804100111 SDH201804100112 SDH201804100113 SDH201804100114 SDH201804100115 SDH201804100116 SDH201804100117 SDH201804100118 SDH201804100119 SDH201804100120 SDH201804100121 SDH201804100122 SDH201804100123 SDH201804100124 SDH201804100125 SDH201804100126 SDH201804100127 SDH201804100128 SDH201804100129 SDH201804100130
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    CA, GA, MO, OH & TX
  • Product Description
    Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
  • Manufacturer
    Exsurco Medical

Manufacturer

Exsurco Medical
  • Manufacturer Address
    Exsurco Medical, 10804 Green Rd, Wakeman OH 44889-9676
  • Manufacturer Parent Company (2017)
    Bettcher Industries Inc.
  • Source
    USFDA