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 Multirate Infusor Devices

  • 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 Multirate Infusor Devicessee related information
Date Initiated by FirmJune 07, 2013
Date PostedJune 27, 2013
Recall Status1 Terminated 3 on June 04, 2014
Recall NumberZ-1601-2013
Recall Event ID 65365
510(K)NumberK011317 
Product Classification Pump, infusion, elastomeric - Product Code MEB
ProductBrand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
Code Information Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP  Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026  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
ActionAn 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 Commerce3,255,096 total
DistributionDistributed Nationwide and in Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MEB
-
-