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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Event Detail

Event ID 67922
Product Type Devices
Status Ongoing
Recalling Firm Fresenius Medical Care Holdings, Inc.
City Waltham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA (nationwide) and Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates Lot Numbers (49 lots) recalled on 4/10/14: 13KMLB001 13LMLB001 14AMLB002 13KMLB002 13LMLB002 14AMLB003 13KMLB003 13LMLB003 14AMLB004 13KMLB004 13LMLB004 14AMLB005 13KMLB005 13LMLB005 14AMLB006 13KMLB006 13LMLB006 14AMLB007 13KMLB007 13LMLB007 14AMLB008 13KMLB008 13LMLB008 14AMLB009 13KMLB009 13LMLB009 14AMLB010 13KMLB010 13LMLB010 14AMLB012 13KMLB011 13LMLB011 13JMLB005 13KMLB012 13LMLB012 13JMLB008 13KMLB013 13LMLB013 13JMLB006 13KMLB014 13LMLB014 13JMLB007 13KMLB015 13LMLB015 13JMLB004 13KMLB016 13LMLB016 13KMLB017 14AMLB001 Expanded Recall (9 lots): 13LMLB005 13LMLB006 14AMLB011 14AMLB013 14AMLB014 14AMLB015 14AMLB016 14AMLB017 14BLMB001 Class I Naturalyte Liquid Bicarbonate maybe contaminated 672,784 units Z-1639-2014