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.
FDA Recall Z-0033-2012 · Posted 2011-10-11
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Recalling FirmIsopure Corp
Recall StatusTerminated
Product CodeFJP
Date Initiated2011-05-19
Date Terminated2013-02-19
Product Quantity11 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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