NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
FDA Recall Z-1827-2015 · Posted 2015-06-22
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2015-05-20
Product Quantity1,856,619 Bottles
Reason for Recall
Bacterial contamination.
Firm Action
Fresenius Medical Care sent an Urgent Medical Device Recall letter dated May 15, 2015, to all affected customers. Users were requested to Immediately examine stock to determine whether they have any Naturalyte Liquid Bicarbonate Concentrate of the lots.
" If any product of these lots is 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.
" Your dialysis schedule should not be interrupted. If interruption of your
dialysis schedule is expected, please discuss your options with your health
care provider.
" Contact FMCNA Customer Service Team at 1-800-323-5188 for
instructions on how to return the recalled product.
" Promptly fill out and return the attached reply form
Additional medical concerns or questions, please contact Medical Information
and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.
For questions regarding this recall call 800-662-1237.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution
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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