Date Initiated by Firm |
September 05, 2008 |
Date Posted |
October 21, 2008 |
Recall Status1 |
Terminated 3 on February 03, 2010 |
Recall Number |
Z-0152-2009 |
Recall Event ID |
49443 |
510(K)Number |
K945942
|
Product Classification |
Infusion Pump - Product Code FRN
|
Product |
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
Indicated for infusion via intravenous, intra-arterial, epidural or subcutaneous routes of administration.
|
Code Information |
Product code 1M8550 serviced or repaired with part numbers AAS5001530RP, AAS5001531RP or A069160000RP between 11/1/07 and 7/29/08. |
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 |
Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Urgent Product Recall letters dated 9/5/08 were sent on the same date via first class mail to the direct accounts, to the attention of the Director of Biomedical Engineering and Facility Risk Manager. If the account had device(s) that had been serviced by Baxter with a part affected by this action, a serial number list of the affected device(s) was provided with the notification. Customers were instructed to remove the affected device(s)/spare parts from service and contact Baxter to arrange for their return and repair. Alternatively, if removal of the device is not a viable alternative for the customer and they wish to perform self-service, the customers will also be provided with a Service Bulletin to provide instruction on replacement of the rear case assembly. |
Quantity in Commerce |
509 units |
Distribution |
Worldwide Distribution --- USA including Puerto Rico, and countries of Canada and Korea. |
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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