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Class 2 Device Recall ExactaMix |
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Date Initiated by Firm |
November 12, 2009 |
Date Posted |
March 09, 2010 |
Recall Status1 |
Terminated 3 on February 24, 2011 |
Recall Number |
Z-1030-2010 |
Recall Event ID |
53893 |
510(K)Number |
K900585
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Product Classification |
total parenteral nutrition bag - Product Code KPE
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Product |
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation. |
Code Information |
Lot numbers: 738391, 738392. |
Recalling Firm/ Manufacturer |
Baxa Corporation 14445 Grasslands Dr Englewood CO 80112
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For Additional Information Contact |
303-690-4204
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Manufacturer Reason for Recall |
TPN bags may leak fluid due to inadequate sealing.
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FDA Determined Cause 2 |
Process control |
Action |
Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292. |
Quantity in Commerce |
646/50 bag cases |
Distribution |
Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = KPE and Original Applicant = BAXA CORP., SUB. OF COOK GROUP, INC.
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