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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Lock Box for 100 mL or 250 mL Bag Set

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  Class 2 Device Recall Baxter Lock Box for 100 mL or 250 mL Bag Set see related information
Date Initiated by Firm September 01, 2004
Date Posted April 22, 2005
Recall Status1 Terminated 3 on July 21, 2006
Recall Number Z-1569-05
Recall Event ID 29958
510(K)Number K002679  
Product Classification Pump, Infusion - Product Code FRN
Product Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information all lot numbers/serial numbers of product codes 2L9354 and 606194
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 pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.
FDA Determined
Cause 2		 Other
Action Urgent Device Correction letters dated 9/1/04 were sent to all U.S. Baxter affected customers on the same date, to the attention of the Director of Nursing. The facilities were advised of the free-flow incident and as a result that Baxter wanted to heighten awareness of the proper clinical procedures for loading the sets into the infusion systems using these Lock Boxes with the 6060 Multi-Therapy Pump. Baxter''s investigation into the event confirmed that the 6060 pump door was left open after the lock box was attached to the pump. Baxter provided copie of the instructions for use of the lock box and pages from the 6060 pump operator''s manual which outline the proper procedure for loading the sets into the the pump and the pump into the lock box. The accounts were requested to complete and fax back to Baxter the enclosed response form, erifying receipt of the letter, confirming that the information has been provided to all users of the infusion system, and allowing Baxter to order and ship labels for the lock box and revised instructions for use to the facility. Any questions were directed to 1-800-843-78867.
Quantity in Commerce 640 units
Distribution Nationwide and internationally to Australia, Belgium, Canada, France, Hong Kong, Portugal, Spain and the United Kingdom.
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 = BAXTER HEALTHCARE CORP.
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