The Recall Desk
HighFDA (Devices)·Z-0134-2020·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 filters. The recall covers 19,350 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 product (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 Non-Vented, Microbore, PAV, 123 Inch. The recall involves 19,350 units, with 1 unit per pouch and 50 pouches per case.

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 during use.

The affected products were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. International distribution included Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, and the United Arab Emirates. The specific lot numbers involved are 855995H, 865505H, and 876185H, associated with Product Code 163840455.

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 Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion Sets
Hazard
Affected units
19,350

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: 163840455
  • Lot number (UDI Number): 855995H (20887787007446
  • 10887787007449)
  • 865505H (20887787007446
  • 876185H (20887787007446

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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