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Terminated

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.

FDA Recall Z-1739-2014 · Posted 2014-06-09

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKPO
Date Initiated2014-05-01
Date Terminated2016-06-15
Product Quantity12 bottles

Reason for Recall

Container cap may contain foreign material- 0.60% - 0.80% Manganese

Firm Action

Fresenius Medical notified customer by letter dated 5/1/14 to examine stock immediately and instructed to discontinue use and place all Naturalyte Liquid Bicarbonate Concentrate in a secure area for return to FMC-RTG. The customer instructed to contact the Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product.

Root Cause

Equipment maintenance

Distribution Pattern

Distributed in the state of MO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071387FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LBFresenius Medical Care North America · 2007-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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