The Recall Desk
HighFDA (Devices)·Z-0128-2020·Announced 2019-10-23

ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.

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 without reported injury.

Plain-English summary

ICU Medical Inc is recalling 1,536 units of Plum Microbore Infusion Sets with Inline Filters. The specific product is labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. The product code is 149530489 and the lot number is 925155H.

The recall is being issued because of a potential for fluid leakage out of the air vents on the inline filters. This defect could compromise the integrity of the infusion set during use.

The affected units were distributed nationwide to numerous U.S. states and territories, as well as internationally to countries including Canada, Chile, France, Germany, and the United Kingdom. Healthcare facilities and consumers who possess these specific infusion sets should stop using them and contact ICU Medical Inc for further instructions.

The recalled product

Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion Pumps and Sets
Hazard
Affected units
1,536

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 (3)

  • Product Code: 149530489
  • Lot number (UDI Number): 925155H (20887787003226
  • 10887787003229)

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

See all →

Same hazard · fluid leakage

See all →