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U.S. Department of Health and Human Services

Class 2 Device Recall Safeline Metriset w/Cassette

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  Class 2 Device Recall Safeline Metriset w/Cassette see related information
Date Initiated by Firm June 30, 2008
Date Posted September 23, 2008
Recall Status1 Terminated 3 on May 05, 2009
Recall Number Z-2409-2008
Recall Event ID 49078
510(K)Number K904518  K921860  
Product Classification Intravascular Administration set - Product Code FRN
Product Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System.
Code Information Lot number 60998903 exp 3/31/2013
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Customer Support Department
800-227-2862
Manufacturer Reason
for Recall		 incorrect burette was packaged with the product
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance.
Quantity in Commerce 840 units
Distribution Nationwide.
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 = KENDALL MCGAW LABORATORIES, INC.
510(K)s with Product Code = FRN and Original Applicant = MCGAW, INC.
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