Events

Recall of Device Recall MRVLS 4W GXL: W1/R RBLS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elcam Medical, 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
    71880
  • Event Risk Class
    Class 2
  • Event Number
    Z-2749-2015
  • Event Initiated Date
    2015-07-19
  • Event Date Posted
    2015-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139296
  • 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
    Pump, infusion, insulin - Product Code LZG
  • Reason
    Punctured blister packages were detected during the packaging process at the manufacturing site. potential for device contamination.
  • Action
    Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.

Device

Device Recall MRVLS 4W GXL: W1/R RBLS
  • Model / Serial
    Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401  Elcam Part Number: 470307; lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901  Elcam Part Number: 471601; lot numbers: 1270239001, 1370266601, 1370271501, 1370278801  Elcam Part Number: 471604; lot numbers: 147029310, 1470306801, 1470310201, 1470312501  Elcam Part Number: 477101; lot numbers: 1270244201, 1370278901, 1470292401, 1470292402, 1470298901, 1470301301, 1470306901, 1470310101, 1470312601  Elcam Part Number: 477102; lot numbers: 1370261201, 1570323201  Elcam Part Number: 477901; lot number: 1370255601  Elcam Part Number: 477904; lot number: 1470300101  Elcam Part Number: 478003; lot numbers: 1370261401, 1370266701, 1370271701, 1370271702, 1370278601, 1370278602, 1470293201, 1470296001, 1470307001, 1470312701, 1570316201  Elcam Part Number: 478004; lot numbers: 1370255001, 1370261501, 1370271801, 1370279001, 1470296101, 1470297801, 1470303801, 1470307101, 1470312801  Elcam Part Number: 478701; lot numbers: 1270244901, 1370261301, 1370271901  Elcam Part Number: 478704; lot numbers: 1470296201, 1470299101, 470307201, 1470312901
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Texas, New Mexico and Pennsylvania
  • Product Description
    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
  • Manufacturer
    Elcam Medical, Inc.

Manufacturer

Elcam Medical, Inc.
  • Manufacturer Address
    Elcam Medical, Inc., 2 University Plz Ste 620, Hackensack NJ 07601-6224
  • Manufacturer Parent Company (2017)
    Elcam Medical, Inc.
  • Source
    USFDA