Silver Spring, Maryland–(ENEWSPF)–May 22, 2014. Fresenius Medical Care North America (FMCNA) announced today that its voluntary recall of 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines) from distribution has been classified as a Class 1 Recall.
The affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.
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). According to a few case reports in the medical literature, 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.
Customer notifications were published on April 10th and May 1st, 2014. The customer notifications (available at www.fmcna.com) include a list of the product lot numbers which should be permanently removed from use and returned.
As part of its voluntary recall, the company informed the U.S. Food and Drug Administration (FDA) and Health Canada, as well as its customers – on April 10th and May 1st, 2014 – about these findings and promptly took steps to remove all of the affected lots from distribution, and discontinue their use.
Customers are encouraged to contact the FDA through the following means if they experience adverse reactions or quality problems from using this product:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
Customers can contact Fresenius Medical Care’s customer service teams at 1-800-323-5188 to report these issues, or if they have additional questions.
About Fresenius Medical Care North America
Through its leading network of more than 2,150 dialysis facilities in North America and vascular access centers, laboratory, pharmacy and affiliated hospitals and nephrology practices, Fresenius Medical Care provides renal services to hundreds of thousands of people throughout the United States, Mexico and Canada. It is also the continent’s top producer of dialysis equipment, dialyzers and related disposable products and a major supplier of renal pharmaceuticals. For more information about the company, visit www.fmcna.com; for information about patient services, visit www.ultracare-dialysis.com.
Source: fda.gov
