Agency classClass IIOur severity:High FDA (Devices)·Z-0140-2020·Announced 2019-10-23

ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk

ICU Medical Inc 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 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 for risk-of-harm products.

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 2,327 units of the product, which is packaged as 1 unit per pouch, 1 unit per blister, and 40 blisters per case. The affected product codes are 163353155, with lot numbers 885685H and 3959757.

The recall was initiated because of a potential for fluid leakage out of air vents on the inline filters. This defect is associated with Plum and Sapphire micropore infusion sets. The source text notes that the product was not distributed in the U.S., despite listing a nationwide distribution pattern to various states and territories, as well as international distribution to multiple countries including Canada, Chile, France, and Germany.

Healthcare facilities and distributors should stop using the affected infusion sets immediately. Users should contact ICU Medical Inc for further instructions on how to return or dispose of the recalled units. No specific consumer action is required for the general public as the product is intended for medical use.

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 Sets
Hazard: fluid-leakage
Affected units: 2,327

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 (3)

Product Code: 163353155
Lot number 885685H
3959757

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

See all →

High
ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · fluid leakage