UPDATE: Fresenius Medical Care North America announced May 1 that is initiating a voluntary recall of nine lots of NaturaLyte Bicarbonate Concentrate 6.4 Liter Bottle( Product Code 08-4000-LB). These nine lots are in addition to the 49 lots currently being recalled, for the same reason, under a notification letter sent to customers April 10.
The additional nine lots include the following:
A list of the 49 lots already under recall provided in the article below.
Fresenius Medical Care North America is initiating a voluntary recall involving 49 lots of NaturaLyteBicarbonate Concentrate 6.4 Liter Bottle (Product Code 08-4000-LB), which were distributed between Aug. 15, 2013 and April 7, 2014.
FMCNA said they have determined the product may contain higher levels of bacterial contamination than allowed by their internal specification. FMCNA said they are currently conducting testing to identify the organism/s. When testing is complete, the identity of the organisms will be provided, according to a memo distributed by FMCNA.
According to the FMCNA memo, no pyrogenic reactions, bacterial infections or related adverse events have been reported, according to FMCNA. Pyrogenic reactions may occur when a patient is exposed to a significant amount of endotoxins, present in the bacterial cell wall of gram negative bacteria, resulting in fever, hypotension, flushing, chills, and/or breathing difficulties. The effects of endotoxins are only temporary. Patients may develop long-range health consequences secondary to the severity of the reaction (i.e., hypotension, breathing difficulties). In addition, a high bioburden in the dialysis concentrate may lead to transient bacteremia, according to the FMCNA memo.
Anyone with one or more bottles of the affected product should do the following:
- Discontinue use immediately.
- Place all units in a secure, segregated area.
- If affected product was on the machine prior to patient treatment, perform a heat disinfect program
- Contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.
- Promptly fill out and return the fax-back reply form.