—#100194

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

FDA product code: KPO — Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K071387
Affected lot / code info: Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)

Why it was recalled

Mislabeled: incorrect lot number printed on case labels

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA

Timeline

Recall initiated: 2011-03-23
Posted by FDA: 2011-06-10
Terminated: 2012-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.