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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; 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.
Recall Number Z-1739-2014
Classification Class III
Code Info Lot Number: 14CMLB006
Product Distributed Qty 12 bottles
Reason For Recall Container cap may contain foreign material- 0.60% - 0.80% Manganese

Event Detail

Event Id 68135
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 2014-05-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the state of MO.
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