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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Sabraset 6060 Set with Preattached 250 mL Bag

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  Class 2 Device Recall Baxter Sabraset 6060 Set with Preattached 250 mL Bag see related information
Date Initiated by Firm May 04, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on July 21, 2006
Recall Number Z-1086-05
Recall Event ID 31969
510(K)Number K002679  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Sabraset 6060 Administration Set with Pre-attached 250 mL Bag and Cassette, product code 560500-250; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico
Code Information product code 560500-250, lots 417521, 418481, 418744 
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 inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
FDA Determined
Cause 2		 Other
Action Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.
Quantity in Commerce 7,516 sets
Distribution Nationwide and internationally to Australia, Belgium, Canada and Japan.
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 = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
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