Events

Recall of Device Recall SCD Express; VasoForce; Benaflow

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Surgical Instrument Service And Savings, 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
    65205
  • Event Risk Class
    Class 2
  • Event Number
    Z-1638-2013
  • Event Initiated Date
    2013-05-03
  • Event Date Posted
    2013-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118483
  • 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
    Sleeve, limb, compressible - Product Code JOW
  • Reason
    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
  • Action
    MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.

Device

Device Recall SCD Express; VasoForce; Benaflow
  • Model / Serial
    122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    - Calf Garment Standard Ref. L501-M Lot 122549, 122985 || - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 || - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 || - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 || - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 || - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 || Compressible limb sleeve. || - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 || - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 || - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 || - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 || - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715
  • Manufacturer
    Surgical Instrument Service And Savings, Inc.

Manufacturer

Surgical Instrument Service And Savings, Inc.
  • Manufacturer Address
    Surgical Instrument Service And Savings, Inc., 2747 Sw 6th St, Redmond OR 97756-7109
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA