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U.S. Department of Health and Human Services

Class 2 Device Recall Infusion Pump Intermate Infusion Pump

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  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-1603-2013
Recall Event ID 65365
510(K)Number K943664  
Product Classification Pump, infusion, elastomeric - Product Code MEB
Product Brand Name: Intermate Infusion Pump.

Indicated for the intravenous administration of medications.
Code Information Product Codes: 2C1064K  Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062  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 = MEB and Original Applicant = BAXTER HEALTHCARE CORP.
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