Date Initiated by Firm | July 14, 2010 |
Date Posted | January 13, 2012 |
Recall Status1 |
Terminated 3 on January 13, 2012 |
Recall Number | Z-0744-2012 |
Recall Event ID |
60520 |
510(K)Number | K063696 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. |
Code Information |
Product Code: 2M8161, Serial Numbers 15051625CC, 15020263CC |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer Reason for Recall | Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system. |
FDA Determined Cause 2 | Employee error |
Action | Baxter sent service technicians to the consignees location on July 14, 2010 and October 6, 2010 and conducted the ground impedance and leakage current test on the affected pumps. The pumps were found with specifications. |
Quantity in Commerce | 2 units |
Distribution | Nationwide 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
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