Agency classClass IIOur severity:High FDA (Devices)·Z-0133-2020·Announced 2019-10-23

ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage

ICU Medical Inc is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.

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 specific Sapphire Microbore Infusion Sets with Inline Filters. The affected products are labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. The recall involves 51,250 units distributed nationwide and internationally.

The recall is being issued 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.

Healthcare facilities and consumers who have these specific infusion sets should stop using them immediately. Affected units can be identified by the product code 163830455 and specific lot numbers listed in the official recall notice. Users should contact ICU Medical Inc for further instructions on how to return or dispose of the recalled products.

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 Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
Manufacturer: ICU Medical Inc
Category: Medical Device — Infusion Sets
Hazard: fluid-leakage
Affected units: 51,250

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: 163830455
Lot number (UDI Number): 855665H (20887787007439
10887787007432)
865495H (20887787007439
896195H (20887787007439
3849197 (20887787007439
4064964 (20887787007439

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