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U.S. Department of Health and Human Services

Class 2 Device Recall ExactaMix TM Valve Set

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  Class 2 Device Recall ExactaMix TM Valve Set see related information
Date Initiated by Firm February 10, 2010
Date Posted March 23, 2010
Recall Status1 Terminated 3 on April 09, 2012
Recall Number Z-1197-2010
Recall Event ID 54773
510(K)Number K002705  
Product Classification Set, i.v. fluid transfer - Product Code LHI
Product Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO.

Intended as tubing for use in compounding, used to connect up to 24 source ingredients.
Code Information Model number: 724, Lot Numbers: 740789 through 742707 (sequentially numbered).
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact
303-690-4204
Manufacturer Reason
for Recall		 Molding defect in the valve body causes leaking.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Baxa Corporation notified customers of the affected product by letter beginning February 10, 2010. Users were instructed to return all affected product to the firm. For further information, contact Baxa Corporation at 1-303-617-2242.
Quantity in Commerce 3230 cases; 32300 units (10 units/case)
Distribution Nationwide Distribution -- Including AL, AR, AZ, CA, CO, DC, MN, IL, NY, DE, FL, PA, IN, TN, MS, MO, TX, MI, MA, MT, MO, SC, VA, WV, NJ, OH, CT, MO, NV, LA, WA, WI, GA, OK, NE, NH, NC, MD, KS, UT, IA, KY, HI, OR, SC, ME and SD.
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 = LHI and Original Applicant = BAXA CORP.
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