Liberty Drain Line Recalled for Freezing Temperature Exposure During Transport
Fresenius Medical Care is recalling 6 cases of 026-20036A Liberty Drain Lines distributed in Texas due to exposure to freezing temperatures during refrigerated truck malfunction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II device recall involves improper storage conditions with no reported injuries or confirmed defects mentioned. This fits the rubric category for voluntary precautionary recalls.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 6 cases of 026-20036A Liberty Drain Line, Luer Tap (Lot 20HR08054, UDI 00840861101115) distributed in Texas. These drain lines are used for peritoneal dialysis in patients with acute and chronic end-stage renal disease in healthcare and home settings.
The recall was initiated because the product was exposed to freezing temperatures due to malfunction of the refrigerated transport truck during shipment.
The recalled product
- Product
- 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 20HR08054 UDI: (01)00840861101115
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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