Events

Recall of Device Recall Uterine Introducing Catheter 5F

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bioteque America 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
    31276
  • Event Risk Class
    Class 2
  • Event Number
    Z-0027-05
  • Event Initiated Date
    2005-02-24
  • Event Date Posted
    2005-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37581
  • 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
  • Reason
    Product is marketed without a 510(k).
  • Action
    The recalling firm telephoned the distributors and sales representatives on 2/23/05 informing them of the problem and the need to return the product. As a follow up to the telephone call, a recall letter dated 2/24/05 was issued to the distributors.

Device

Device Recall Uterine Introducing Catheter 5F
  • Model / Serial
    Lot number 741105 exp 11/07
  • Distribution
    The products were shipped to distributors in OH and MI. The product was also provided to sales representatives.
  • Product Description
    Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch
  • Manufacturer
    Bioteque America Inc

Manufacturer

Bioteque America Inc
  • Manufacturer Address
    Bioteque America Inc, 340 E Maple Ave Ste 204c, Langhorne PA 19047-2848
  • Source
    USFDA