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
FDA Recall Z-2551-2011 · Posted 2011-06-10
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2011-03-23
Date Terminated2012-09-12
Product Quantity3,190 cases
Reason for Recall
Mislabeled: incorrect lot number printed on case labels
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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