Date Initiated by Firm |
March 24, 2011 |
Date Posted |
April 29, 2011 |
Recall Status1 |
Terminated 3 on April 29, 2011 |
Recall Number |
Z-2122-2011 |
Recall Event ID |
58482 |
510(K)Number |
K915522
|
Product Classification |
Pump, infusion - Product Code FRN
|
Product |
Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063
The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.
|
Code Information |
Serial numbers 6100410FA, 8110687FA and 11021746FA |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
|
For Additional Information Contact |
800-422-9837
|
Manufacturer Reason for Recall |
Pumps submitted for service may not have been properly serviced before being returned to the customer.
|
FDA Determined Cause 2 |
Employee error |
Action |
Baxter visited the direct accounts starting on 3/24/11 informing them that the affected Flo-Gard pumps may have been released from the preventative maintenance with incorrect accuracy testing. The affected pumps were located, taken out of service and placed in quarantine on the same date. A technician not involved with the previous testing visited both accounts on 3/25/11 and performed preventative maintenance service of the three affected devices, and were found to be within specification. |
Quantity in Commerce |
3 units |
Distribution |
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.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORP.
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