Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: fluid-leakage
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 →

Same manufacturer · ICU Medical Inc

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Same hazard · fluid leakage