The Recall Desk
HighFDA (Devices)·Z-0126-2020·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. The recall covers 170,735 units distributed nationwide and internationally.

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 is classified as FDA Class II, and the hazard involves a risk of harm (fluid leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

ICU Medical Inc is recalling specific Plum Microbore Infusion Sets with Inline Filters. The affected products are labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convertible Pin, 104 Inch with Orange Polyethylene-Lined/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. The recall involves 170,735 units.

The recall is being conducted 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 agency has classified this as a Class II recall.

The affected products were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. They were also distributed internationally to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, and the United Arab Emirates. Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 uni
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion Sets
Hazard
Affected units
170,735

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 (11)

  • Product Code: 118790412
  • Lot number (UDI Number): 855505H (20887787009020
  • 10887787009023)
  • 865135H (20887787009020
  • 918695H (20887787009020
  • 928085H (20887787009020
  • 937325H (20887787009020
  • 3864774 (20887787009020
  • 3935434 (20887787009020
  • 4011065 (20887787009020
  • 4088425 (20887787009020

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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