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Class 3 Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate |
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Date Initiated by Firm |
March 23, 2011 |
Date Posted |
June 10, 2011 |
Recall Status1 |
Terminated 3 on September 12, 2012 |
Recall Number |
Z-2551-2011 |
Recall Event ID |
58736 |
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@ 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 |
Code Information |
Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005) |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Waltham MA 02451-1521
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For Additional Information Contact |
Denise Oppermann 800-662-1237
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Manufacturer Reason for Recall |
Mislabeled: incorrect lot number printed on case labels
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FDA Determined Cause 2 |
Employee error |
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. |
Quantity in Commerce |
3,190 cases |
Distribution |
Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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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