Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Infusion Pump Intermate Infusion Pump

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Infusion Pump Intermate Infusion Pump see related information
Date Initiated by Firm June 07, 2013
Date Posted June 27, 2013
Recall Status1 Terminated 3 on June 04, 2014
Recall Number Z-1604-2013
Recall Event ID 65365
510(K)Number K910425  
Product Classification Pump, infusion - Product Code FRN
Product Brand Name: Intermate Infusion Pump.

Indicated for the intravenous administration of medications.
Code Information Product Codes: 2C1730K, 2C1732K, 2C1734K, 2C1740K, 2C1743K, 2C1744K  Lot Codes: 10F009 10F049 10F053 10F057 10F095 10J006 10J079 10K077 10M067 10F004 10F015 10G016 10G017 10G018 10G019 10G053 10G054 10H007 10H008 10H009 10H049 10H050 10H051 10H079 10H080 10H081 10H108 10J002 10J009 10J011 10J012 10J077 10J078 10J083 10K009 10K010 10K011 10K012 10K014 10K018 10K070 10K071 10K072 10M015 10M061 10M066 10M071 10M073 10M074 10M082 10F010 10F011 10F079 10G021 10G022 10G023 10H010 10H025 10H026 10H047 10J003 10J004 10J005 10J080 10J081 10J082 10J093 10K016 10K017 10K019 10M008 10M010 10M075 10M078 10M080 10M081 10H083 10M065 10F051 10F073 10G039 10G040 10J007 10J008 10J109 10K007 10K057 10K106 10M064 10M070 10F005 10F006 10F052 6/19/2010  6/22/2010  6/23/2010  8/13/2010  8/23/2010  8/30/2010  9/3/2010  9/30/2010  10/4/2010  10/21/2010  10/26/2010  11/4/2010  11/15/2010  11/24/2010   Expiration Date: 06/30/13
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Route 120 And Wilson Rd
Round Lake IL 60073-9799
For Additional Information Contact
847-270-5556
Manufacturer Reason
for Recall		 Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.
Quantity in Commerce 3,255,096 total
Distribution Distributed Nationwide and in Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
-
-