Events

Recall of Device Recall Baxter Minicap Extended Life PD Transfer Set Extra SHort (4") with Twist Clamp

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

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
    52560
  • Event Risk Class
    Class 2
  • Event Number
    Z-1894-2009
  • Event Initiated Date
    2009-07-02
  • Event Date Posted
    2009-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83935
  • 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
    Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Reason
    The peritoneal dialysis transfer set has a defective white sleeve twist clamp. the twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.
  • Action
    Baxter Healthcare Corporation telephoned the accounts receiving the affected lots and then faxed or e-mailed "Urgent Product Recall" letters dated July 2, 2009, to them, to the attention of the Peritoneal Dialysis Nurse, to inform them of the defective white sleeve twist clamp, which may result in leakage and possible peritonitis. The accounts were asked to immediately discontinue the use of the affected lot numbers and examine their inventory for the affected lots. If any affected product was found, they were requested to quarantine it and contact Baxter Center for Service at 1-888-229-0001 to arrange for its return to Baxter. The accounts were also requested to review their patient records to determine if any of their patients had received the affected product. If so, they were advised to contact the patients to see if they had experienced any leaking. If so, the patients should return to the facility to have the set changed per the facility's transfer set change procedure. Any questions were directed to the Center for One Baxter at 1-800-422-9837, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Standard Time (CST). The accounts were requested to complete the enclosed reply form acknowledging receipt of the letter and that they followed the instructions and disseminated the information to their staff.

Device

Device Recall Baxter Minicap Extended Life PD Transfer Set Extra SHort (4") with Twist Clamp
  • Model / Serial
    Product code 5C4483, lot number H09E18044.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.
  • Product Description
    Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA