The Recall Desk
HighFDA (Devices)·Z-0130-2020·Announced 2019-10-23

ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid may leak out of the air vents. The recall covers 45,900 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 Sapphire Microbore Infusion Sets with Inline Filters, specifically the SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. The recall involves 45,900 units. The product is identified by Product Code 163620455 and specific lot numbers including 855645H, 885415H, 896625H, and 4008547.

The recall was initiated due to a potential for fluid leakage out of the air vents on the inline filters. This defect is associated with Plum and Sapphire micropore infusion sets. The affected products were distributed nationwide to all 50 states, DC, Puerto Rico, and the U.S. Virgin Islands, as well as internationally to 18 countries including Canada, the United Kingdom, and Germany.

Healthcare facilities and consumers should stop using the affected infusion sets immediately. Users should check their inventory for the specific product code and lot numbers listed in the recall notice. For more information, refer to the FDA recall number Z-0130-2020.

The recalled product

Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
Manufacturer
ICU Medical Inc
Category
Medical Device — Infusion Pumps and Sets
Hazard
Affected units
45,900

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 (7)

  • Product Code: 163620455
  • Lot number (UDI Number): 855645H (20887787007354
  • 10887787007357)
  • 885415H (20887787007354
  • 896625H (20887787007354
  • 4008547 (10887787007357
  • 20887787007354)

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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