The Recall Desk
ModerateFDA (Devices)·Z-2085-2021·Announced 2021-07-28

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.

What this means for you

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
  • freezing-exposure

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:

  • TX