Events

Recall of Device Recall Reserve, Cassette, CADD, 100ml, mdl 2100, 21700224

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical MD, 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
    38306
  • Event Risk Class
    Class 2
  • Event Number
    Z-1215-2007
  • Event Initiated Date
    2007-06-18
  • Event Date Posted
    2007-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53379
  • 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
    Medication Cassette Reservoir - Product Code FPA
  • Reason
    Smith medical has become aware that an increase in ph may occur with some medications when instilled in the affected cassettes. also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering flolan.
  • Action
    All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD.

Device

Device Recall Reserve, Cassette, CADD, 100ml, mdl 2100, 21700224
  • Model / Serial
    081X16, 082X16, 085X16, 088X16, 089X16, 090X16, 091X16, 094X16, 095X16, 096X16, 097X16, 104X16, 105X16, 106X16, 107X16, 109X16, 110X16, 112X16, 113X16, 115X16, 119X16, 120X16, 121X16, 122X16, 123X16, 128X16, 129X16, 136X16, 138X16, 142X16, 144X16, 145X16, 149X16, 152X16, 154X16, 155X16, 157X16, 160X16, 161X16, 163X16, 164X16, 167X16, 168X16, 169X16, 170X16, 171X16, 172X16, 173X16, 176X16, 177X16, 179X16, 182X16, 183X16, 186X16, 187X16, 189X16, 190X16, 192X16, 195X16, 196X16, 199X16, 200X16, 203X16, 204X16, 206X16, 207X16, 209X16, 210X16, 211X16, 212X16, 213X16, 214X16, 216X16, 218X16, 220X16, 221X16, 222X16, 223X16, 228X16, 229X16
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.
  • Product Description
    Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC || 4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Manufacturer Address
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA