Events

Recall of Busse Suction Instrument with Tubing

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

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
    28815
  • Event Risk Class
    Class 2
  • Event Number
    Z-0843-04
  • Event Initiated Date
    2004-04-13
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32555
  • 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
    Unit, Suction Operatory - Product Code EBR
  • Reason
    Firm received complaints of "melting" at tubing connection. the connecting part of the yankauer becomes soft after extended direct contact with the pvc tubing. this results in a slower rate of suction.
  • Action
    Urgent Product Recall Letters and Response Forms were sent to the consignees via Registered Mail on 4/13/04.

Device

Busse Suction Instrument with Tubing
  • Model / Serial
    Barcode: * +H8003021T*. Lots: 0020404, 0020421, 0020539, 0020567, 0020578, 0020578, 0020641, 0020933, 0020982, 0021060, 0021067, 0021262, 0021366, 0022027, 0120089, 0120146, 0120217, 0120285, 0120342, 0120427, 0120491,  0120626, 0120697, 0120753, 0120866, 0120968, 0121063,  0121172, 0121403, 0220079, 0220201, 0220305, 0220348,  0220424, 0220474, 0220509, 0220522, 0220673, 0220683,  0220847, 0220927, 0220956, 0320185, 0320194, 0320208,  0320243, 0320267, 0320335, 0320343, 0320391, 0320392, 0320412, 0320438, 0320438, 0320485, 0320504, 0320536, 0320558, 0320582, 0320609, 0320642.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributors and end users (hospitals, fire departments/EMS) located nationwide, in Puerto Rico, St. Thomas, Canada, Dominican Republic, Panama, Uganda, Dubai, and Abu Dhabi, United Arab Emirates.
  • Product Description
    Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made in Mexico. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510(k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
  • Manufacturer
    Busse Hospital Disposables

Manufacturer

Busse Hospital Disposables
  • Manufacturer Address
    Busse Hospital Disposables, 75 Arkay Drive, Hauppauge NY 11788-3707
  • Source
    USFDA