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Class 2 Device Recall Fresenius NaturaLyte |
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Date Initiated by Firm |
May 20, 2015 |
Date Posted |
June 22, 2015 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1827-2015 |
Recall Event ID |
71160 |
510(K)Number |
K071387
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Product Classification |
Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
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Product |
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. |
Code Information |
Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB. |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Waltham MA 02451-1521
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For Additional Information Contact |
800-662-1237
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Manufacturer Reason for Recall |
Bacterial contamination.
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FDA Determined Cause 2 |
Process control |
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. |
Quantity in Commerce |
1,856,619 Bottles |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = KPO and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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