Agency classClass IIOur severity:High FDA (Devices)·Z-0141-2020·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 due to a potential for fluid leakage out of 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 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 311 cm / 8.4 mL. The recall involves 32,416 units distributed nationwide to multiple U.S. states and internationally to countries including Canada, Chile, France, and Germany.

The recall is being conducted because of a potential for fluid leakage out of the air vents on the inline filters. The affected product codes are 163359255, and the specific lot numbers are 855875H, 866155H, 876265H, 885645H, 887125H, 905965H, and 945565H.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected infusion sets if found. The source text does not report any specific illnesses or injuries associated with this defect.

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 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
Manufacturer: ICU Medical Inc
Category: Medical Device — Infusion Pumps and Sets
Hazard: fluid-leakage
Affected units: 32,416

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 (8)

Product Code: 163359255
Lot number 855875H
866155H
876265H
885645H
887125H
905965H
945565H

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