Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 51
FDA device recall Z-0033-2012 · posted 2011-10-11 · Terminated
Recall details
- Recalling firm
- Isopure Corp
- 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 taken
- 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
- Status
- Terminated
- Product code
- FJP
- Quantity affected
- 11 units
- Distribution
- Nationwide Distribution including AR, CT, GA, MA, ME, NJ, PA, TN and WV.
- Date initiated
- 2011-05-19
- Date posted
- 2011-10-11
- Date terminated
- 2013-02-19
- Location
- Simpsonville, KY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM (K993272) | Pure Water, Inc. | 2000-04-10 |