Date Initiated by Firm |
December 01, 2010 |
Date Posted |
January 21, 2011 |
Recall Status1 |
Terminated 3 on May 13, 2011 |
Recall Number |
Z-0931-2011 |
Recall Event ID |
57515 |
510(K)Number |
K063696
|
Product Classification |
Pump, infusion - Product Code FRN
|
Product |
Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161 |
Code Information |
Product Code: 2M8161, serial number 15030799CC |
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 |
While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
|
FDA Determined Cause 2 |
Employee error |
Action |
Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost.
For questions regarding this recall call (800) 437-5176. |
Quantity in Commerce |
1 pump |
Distribution |
Texas |
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 = FRN and Original Applicant = BAXTERHEALTHCARE, INC.
|