The Recall Desk
HighFDA (Devices)·Z-0145-2020·Announced 2019-10-23

ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.

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: The recall involves a medical device with a functional defect (fluid leakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets with Inline Filters. The affected products are labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. The recall involves specific lot numbers: 896485H, 915625H, and 3850054.

The recall was initiated due to a potential for fluid leakage out of the air vents on the inline filters. This defect could compromise the integrity of the infusion system.

The affected products were distributed nationwide to 48 states and territories, as well as internationally to 19 countries including Canada, France, Germany, and the United Kingdom. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical Inc for instructions on return or replacement.

The recalled product

Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion Pumps and Sets
Hazard
Affected units
7,920

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 (5)

  • Product Code: 240070401
  • Lot number (UDI Number): 896485H (20887787009228
  • 10887787009221)
  • 915625H (20887787009228
  • 3850054 (20887787009228

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 22 recalled by ICU Medical 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.

See all 22 products in this recall →

Related recalls

Same manufacturer · ICU Medical Inc

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Same hazard · fluid leakage

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