CLASS II Device recall · Reported 28 Jul 2021 · FDA Enforcement Report

08-4078-BB Bibag/Case 08-4080-BB Bibag/case For patients recalled

Fresenius Medical Care Holdings is recalling 08-4078-BB Bibag/Case 08-4080-BB Bibag/case For patients with acute and chronic end stage, distributed in Texas. The recall was initiated on 28 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(1) Lot Number: B4MA27140 BAG GTIN CASE GTIN BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310 (2) Lot Number: B5MB24110 BAG GTIN CASE GTIN BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327

Quantity recalled(1) 20 cases (2) 30 cases

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-2082-2021
FDA event ID: 87998
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Terminated
Recall initiated: 28 Apr 2021
FDA classified: 16 Jul 2021
Reported: 28 Jul 2021
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

28 Apr 2021	Recall initiated by company
16 Jul 2021	Classified by FDA	+79 days
28 Jul 2021	Published in enforcement report	+12 days

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

Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

(1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 grams/bag 12 bags/case For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting GRANUFLO & NATURALYTE: Concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.

Where it was distributed

US Distribution to: TX only

Texas

Questions about this recall

Why was it recalled?

Exposed to freezing temperatures due to refrigerated truck malfunctions

Which lots are affected?

(1) Lot Number: B4MA27140 BAG GTIN CASE GTIN BIBAG 650 GRAMS 08-4078-BB 00840861101313 10840861101310 (2) Lot Number: B5MB24110 BAG GTIN CASE GTIN BIBAG 900 GRAMS 08-4080-BB 00840861101320 10840861101327

Where was it sold?

US Distribution to: TX only

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.

Other products in this recall event

8 other products · FDA event 87998

This product is part of a recall event; the main page for the event is Citrasate Liquid Acid Concentrate recalled by Fresenius Medical Care.

Reported	Class	Recall	Company	Reason	Where
28 Jul 2021	CLASS II	Citrasate Liquid Acid Concentrate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	The Drain Bag Set (tubings and flexible bags) is a passive recalled	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	Citrasate Dry Acid Concentrate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	The Fresenius APD Luer-Lock Adapter recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	026-20036A Liberty Drain Line, Luer Tap For patients recalled	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	NaturaLyte Dry Bicarbonate Concentrate is composed recalled	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	The MTS Set is a single-use, sterile (EO), non-pyrogenic recalled	Fresenius Medical Care Holdings	Temperature Abuse	TX
28 Jul 2021	CLASS II	050-95012 Sterile Stay Safe Cap recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Temperature Abuse	TX

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