Product Description
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.
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.
Action Details
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.
Distribution Pattern
Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.
Code Information / Serial Numbers
Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012.
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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.