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
Hazard
Mislabeled: incorrect lot number printed on case labels
What You Should Do
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.
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Products
- Brand
- Fresenius Medical Care Holdings, Inc.
- UPC
- Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
Units Affected
3,190 cases