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U.S. Department of Health and Human Services

Class 3 Device Recall Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model MD380

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  Class 3 Device Recall Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model MD380 see related information
Date Initiated by Firm May 19, 2011
Date Posted October 11, 2011
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-0033-2012
Recall Event ID 59879
510(K)Number K993272  
Product Classification Tank, holding, dialysis - Product Code FJP
Product Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY

System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.
Code Information Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012.
Recalling Firm/
Manufacturer		 Isopure Corp
141 Citizens Blvd
Simpsonville KY 40067-6548
For Additional Information Contact
502-722-1000
Manufacturer Reason
for Recall		 Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.
FDA Determined
Cause 2		 Software design
Action Isopure sent a letter dated May 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Isopure devised an immediate solution which must be implemented at their faclity in conjunction with the disinfection procedure. Customers were asked to inform all appropriate personnel, clinical and technical, who may be involved in operating the system during the normal disinfection schedule. On 5/19/2011, the firm sent letters to their customers via US mail and email. They also telephoned their customers to notify them of the problem.
Quantity in Commerce 11 units
Distribution Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.
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 = FJP and Original Applicant = PURE WATER, INC.
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