Z-2551-2011

Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number...

Name: Z-2551-2011 Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2011-03-23
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2011-03-23 / Terminated / root cause: manufacturing process

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB Formulated to be used with a three... on 2011-03-23. The reason FDA records is "Mislabeled: incorrect lot number printed on case labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2551-2011
Status: Terminated
Initiated: 2011-03-23
Posted: 2011-06-10
Terminated: 2012-09-12
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid Part number: 08-4000-LB Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Mislabeled: incorrect lot number printed on case labels
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove the correctly labeled product from the incorrectly labeled case and discard the case. Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients. Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.
Quantity in commerce: 3,190 cases
Distribution: Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
Product codes and lots: Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)

Product code KPO

K071387Class IIFresenius Naturalyte Sodium Bicarbonate Liquid Concentrate, Model 08-4000-LbFresenius Medical Care North America / cleared 2007-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)