Events

Recall of Winged Infusion Sets

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access Systems, 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
    27431
  • Event Risk Class
    Class 2
  • Event Number
    Z-0098-04
  • Event Initiated Date
    2003-09-23
  • Event Date Posted
    2003-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29865
  • 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
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Reason
    Sterility of product is compromised by open seals in packaging.
  • Action
    Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.

Device

Winged Infusion Sets
  • Model / Serial
    Product Code 0603300 Gauge size 20 needle length 1.5'' Lot # 22FN4059; Product Code 0604190 Gauge Size 20 Needle Length 0.75'' Lot # 22FN4062; Product Code 0604200 Gauge Size 20 Needle Length 1.0'' Lot # 22KM1206, # 22KM1209, # 22KM1220; Product Code 0604210 Gauge Size 22 Needle Length 0.75'' Lot # 22KM1207; Product Code 0604220 Gauge Size 22 Needle Length 1.0'' Lot # 22KM1210; Product Code 0604270 Gauge Size 20 needle Length 0.5'' Lot # 22KM1211; Product Code 2205220 Gauge Size 20 Needle Length 0.75''  Lot # 22KM1213, # 22KM1214, # 22KM1215,   # 22KM1216, # 22KM1217, #22KM1222,   # 22KM1223, # 22KM1224, # 22KMX222,   # 22KMX223, # 22KMX224, # 22FN4057;  Product Code 2205222, Gauge Size 22 Needle Length 0.75'', Lot # 22FN4056;  Product Code 2206219 Gauge Size 19 Needle Length 1.0'', Lot # 22KM1218, # 22KM1219; Product Code 2206220, Gauge size 19 Needle Length 1.0'', Lot # 22KM1225, # 22KM1219.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.
  • Product Description
    Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
  • Manufacturer
    Bard Access Systems, Inc

Manufacturer

Bard Access Systems, Inc
  • Manufacturer Address
    Bard Access Systems, Inc, 5425 W Amelia Earhart Dr, Salt Lake City UT 84116
  • Source
    USFDA