FDA Device recall Z-1639-2014
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three s…
- FDA Device
- Class I
- ongoing
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class I recall of Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three s… by Fresenius Medical Care Holdings, citing naturalyte Liquid Bicarbonate maybe contaminated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1639-2014 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2014-04-10 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
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
Reason
Naturalyte Liquid Bicarbonate maybe contaminated
Identifiers
| code_info | Lot Numbers (49 lots) recalled on 4/10/14: 13KMLB001 13LMLB001 14AMLB002 13KMLB002 13LMLB002 14AMLB003 13KMLB003…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 Lorem ipsum dolor sit amet, consectetur adipiscing elit. Praesent at nibh ullamcorper, accumsan lectus at, tincidunt enim. Proin aliquet augue non dolor cursus, a luctus purus porttitor. Nulla facilisi. Nulla facilisi. Ut tincidunt eros ut fermentum iaculis. Vestibulum vel ornare tortor, id |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1639-2014%22
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