Recall Z-0033-2012 ยท FJP Adaptor, Y
Isopure Corp
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.
| Date | Oct 11, 2011 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line. |
| 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 p |
| Quantity | 11 units |
| Distribution | Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993272 | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM Pure Water, Inc., Apr 10, 2000 |