CLASS II ONGOING Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

NaturaLyte Liquid Bicarbonate Concentrate recalled

Fresenius Medical Care Holdings is recalling NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), distributed nationwide in the US. The recall was initiated on 20 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAffected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.

Quantity recalled1,856,619 Bottles

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1827-2015
FDA event ID: 71160
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 20 May 2015
FDA classified: 22 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 May 2015	Recall initiated by company
22 Jun 2015	Classified by FDA	+33 days
1 Jul 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Bacterial contamination.

Product as listed by the FDA

NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Bacterial contamination.

Which lots are affected?

Affected lots begin with: 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB.

Where was it sold?

Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide