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 Baxter IPump Pain Management System 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 Baxter IPump Pain Management System Infusion Pump see related information
Date Initiated by Firm February 10, 2005
Date Posted November 16, 2005
Recall Status1 Terminated 3 on November 03, 2008
Recall Number Z-0130-06
Recall Event ID 31191
510(K)Number K993387  
Product Classification Pump, Infusion - Product Code FRN
Product Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information product codes 2L3107 and 2L3107R, all serial numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.
FDA Determined
Cause 2		 Other
Action Baxter mailed Urgent Device Correction letters dated 2/10/05 to the domestic accounts on 2/10/05 via first class mail, to the attention of the Director of Nursing, advising them of the following hardware problems and software anomalies and providing workarounds for each. There are potential failures of the pump due to upstream occlusion alarms, electro-static discharge, Key-Only security mode (previously covered by letter dated 4/10/02), system error 32 or 33 codes, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. The accounts were advised that as soon as revised software and hardware is available, Baxter would modify the pumps at no additional charge to the consignee. Any questions were directed to their Baxter Medication Delivery Product Information Center at 1-800-933-0303.
Quantity in Commerce 24,009 pumps
Distribution Nationwide including Puerto Rico, and internationally through Baxter subsidiaries in Canada, Chile, Hong Kong, Kuwait and Saudi Arabia.
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.
-
-