Hemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport
Fresenius Medical Care is recalling Citrasate and GranuFlo Dry Acid Concentrates after freezing temperature exposure during refrigerated truck transport. Affected lots distributed in Texas should be discontinued immediately.
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: FDA Class II medical device with potential safety implications if freezing compromised product integrity in critical dialysis treatment. No illnesses or injuries reported; theoretical hazards without reported harm are capped at High per the rubric.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate used in hemodialysis treatment. These products are components of the dialysate preparation system used in 45X proportioning hemodialysis machines to generate the fluid needed for blood filtration during kidney dialysis.
The recall was initiated because products were exposed to freezing temperatures due to malfunctions in refrigerated trucks during distribution. Freezing exposure could compromise the product integrity and proper function of these medical concentrates.
The affected products were distributed to healthcare facilities in Texas. Three lots are involved in this recall: 21ATGF013, 20SXGF010, and 20SXGF013. Facilities should discontinue use of products from these lots.
The recalled product
- Product
- Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- freezing-damage
Distribution
Distributed in 1 state:
- TX
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