Date Initiated by Firm |
August 26, 2011 |
Date Posted |
October 28, 2011 |
Recall Status1 |
Terminated 3 on October 31, 2011 |
Recall Number |
Z-0134-2012 |
Recall Event ID |
60168 |
510(K)Number |
K915523
|
Product Classification |
Pump, infusion - Product Code FRN
|
Product |
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064.
The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
|
Code Information |
product code 2M8064, serial number 8110057FB |
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 |
The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.
|
FDA Determined Cause 2 |
Employee error |
Action |
A Baxter Healthcare technician initially notified the sole customer on August 26, 2011 of the defective product and requested that the product be quarantined. On September 14, 2011 a technician visited the site to correct the problem observed on the Flo-Gard Infusion Pump. All required tests were performed and the results were found acceptable. |
Quantity in Commerce |
1 unit |
Distribution |
Distributed only in Puerto Rico. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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