Hemodialysis concentrate recalled for freezing exposure during transport
Fresenius Medical Care recalls Granuflo and Naturalyte hemodialysis concentrate affected by freezing temperatures during refrigerated truck transport. Freezing may compromise product sterility and safety.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall affecting a critical medical device used by patients with end-stage renal disease. While no illnesses or injuries have been reported, exposure to freezing can compromise the sterility and safety of a hemodialysis solution used in vulnerable patients, representing a risk-of-harm scenario without reported adverse events.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Granuflo and Naturalyte hemodialysis concentrate due to exposure to freezing temperatures during transport in refrigerated trucks.
The affected products are: 08-4078-BB BIBAG 650g bags in 16-bag cases (20 cases total, Lot Number B4MA27140) and 08-4080-BB BIBAG 900g bags in 12-bag cases (30 cases total, Lot Number B5MB24110).
These concentrates are used by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in healthcare and home settings. All affected product was distributed to Texas. Exposure to freezing temperatures can compromise the sterility and chemical composition of the hemodialysis solution.
Patients and healthcare providers who have received products with these lot numbers should not use the affected product and should contact Fresenius Medical Care Holdings, Inc. immediately for guidance.
The recalled product
- Product
- (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 conjunct
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- freezing-exposure
- sterility-compromise
Distribution
Distributed in 1 state:
- TX
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