UPDATED 05/28/2014. Recall classified as Class I.
AUDIENCE: Nephrology, Nursing
ISSUE: Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). Bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely.
The affected lots are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.
BACKGROUND: Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity (salt concentration).
RECOMMENDATION: A list of the 56 lot numbers of product which should be permanently removed from use and returned is available at www.fmcna.com . Customer notifications were published on April 10th and May 1st, 2014.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178