Recall Class: Class I
Date Recall Initiated: April 4, 2014
Product(s): NaturaLyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle – Part Number: 08-4000-LB
The affected products were manufactured August 2013 to April 2014 and distributed August 15, 2013 to April 7, 2014.
Use: NaturaLyte Liquid Bicarbonate Concentrate is used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated for use with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
Fresenius Medical Care Holdings, Inc.
920 Winter Street
Waltham, MA 02451-1521
Reason for Recall: The product may develop higher than expected bacteria levels during its shelf life. Lab testing identified the bacteria as Halomonas (species 1, 2, 3), a gram negative bacteria typically found in water with high salt concentration.
The FDA has received one report of death and two reports of injury that may be related to use of this product.
The use of affected product may cause serious adverse health consequences, including sepsis, bacteremia, and death.
Public Contact: Customers can contact Fresenius Medical Care Customer Service at 800-323-5188, 7:00 a.m. – 6:00 p.m., Central Time
FDA District: New England District Office
More Information about this Recall: Fresenius notified customers of the problem through “Urgent Medical Device Recall” letters on April 10, 2014 and May 1, 2014. Customers should:
- Immediately examine their stock to determine whether they have any of the products from the lots listed above.
- If any of these lots are found, 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 the 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 attached to the “Urgent Medical Device Recall” letter.
These actions are not expected to cause a device shortage.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
- Voluntary Nationwide and Canada Recall of NaturaLyte® Liquid Bicarbonate Concentrate Due to Potential Health Risk (Press Release)
- Urgent Medical Device Recall – FMCNA NaturaLyte Liquid Bicarbonate Concentrate (April 10, 2014)