Events

Recall of Device Recall Quinton BETACAP Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Renal Div.

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
    58845
  • Event Risk Class
    Class 2
  • Event Number
    Z-2747-2011
  • Event Initiated Date
    2011-05-19
  • Event Date Posted
    2011-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100404
  • 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
    System, peritoneal automatic delivery - Product Code FKX
  • Reason
    A change made in the quinton beta-cap adapter used to connect the patient pd catheter to the baxter transfer set has resulted in a reduction in thread engagement which may lead to an increased risk of separation and the potential to develop peritonitis.
  • Action
    Baxter sent an URGENT PRODUCT RECALL letter dated May 19, 2011, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter described the problem of loose connections when using the Quinton BETA-CAP with Baxter transfer sets. Baxter requested the dialysis centers to contact their patients currently using a Quinton BETA-CAP adapter to schedule an office visit with their attending physician as soon as practical to have the connection inspected or replaced. If they choose to continue use of the Quinton BETA-CAP adapter, Baxter recommends the clinician exercise extra caution and vigilance to ensure the connection between the Quinton BETA-CAP adapter and the Baxter Transfer Set is secured and tight. The clinicians were instructed to also check their inventory for the Quinton Beta Cap adapter 8814-661001 purchased directly from Baxter, and contact Baxter at 888-229-0001 to arrange for the return and credit of the unused product. Baxter recommends that the Covidien BETA CAP adapter no longer be used and to instead exclusively use the Baxter Titanium Adapter (5C4129) which has sufficient thread geometry for maintaining a secure connection with the Baxter Transfer Set. The customers were also instructed to complete and fax the enclosed customer reply form to (847) 270-5457, indicating the quantity of Quinton Beta Cap adapters being returned and acknowledging the understanding and dissemination of the information in the letter.

Device

Device Recall Quinton BETACAP Adapter
  • Model / Serial
    All lots of Quinton BETA-CAP Adapters, product code 8814-661001, sold by Baxter under product code 5K4560
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall -- Nationwide Distribution
  • Product Description
    Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to connect the catheter to the PD transfer set; Covidien product code 8814-661001, Baxter product code 5K4560
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd, Mc Gaw Park IL 60085-6730
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA