Z-0033-2012

Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102...

Name: Z-0033-2012 Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102...
Creator: Isopure Corp
Published: 2011-05-19
License: https://open.fda.gov/license/

Isopure Corp / initiated 2011-05-19 / Terminated / root cause: software

FDA source

Isopure Corp began a recall of Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007... on 2011-05-19. The reason FDA records is "Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0033-2012
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-10-11
Terminated: 2013-02-19
Recalling firm: Isopure Corp
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.
Product code: FJP Adaptor, Y
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012.

Product code FJP

K993272Class IIPure Water, Inc.'s Bicarb Mix, Storage and Distribution SystemPure Water, Inc. / cleared 2000-04-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)