The Recall Desk
HighFDA (Devices)·Z-0129-2020·Announced 2019-10-23

ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

ICU Medical is recalling Sapphire 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 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 Sapphire Microbore Infusion Sets with Inline Filters, specifically the SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. The recall involves 73,710 units distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as internationally to 18 countries including Canada, the United Kingdom, and Germany.

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 set during use.

Healthcare facilities and consumers who have these specific infusion sets should stop using them and contact ICU Medical Inc for instructions on how to return or dispose of the product.

The recalled product

Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion Sets
Hazard
Affected units
73,710

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 (10)

  • Product Code: 163350455
  • Lot number (UDI Number): 855935H (20887787007316
  • 10887787007319)
  • 855965H (20887787007316
  • 876145H (20887787007316
  • 885395H (20887787007316
  • 896135H (20887787007316
  • 936605H (20887787007316
  • 3843263 (20887787007316
  • 3864786 (20887787007316

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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