Agency classClass IIOur severity:Severe FDA (Devices)·Z-0132-2020·Announced 2019-10-23

ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage

ICU Medical is recalling Sapphire Epidural Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 26,700 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices, are categorized as Severe (Score 4).

Plain-English summary

ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters, specifically the Sapphire Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. The recall involves 26,700 units. The product is identified by Product Code 163730455 and specific lot numbers including 896225H, 916845H, 925825H, and 948155H.

The recall is being conducted 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. The agency has classified this as a Class II recall.

The affected products were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. International distribution included Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, and the United Arab Emirates. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical for instructions on return or replacement.

The recalled product

Product: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Manufacturer: ICU Medical Inc
Category: Medical Device — Infusion Sets
Hazard: fluid-leakage
Affected units: 26,700

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 (6)

Product Code: 163730455
Lot number (UDI Number): 896225H (20887787007408
10887787007401)
916845H (20887787007408
925825H (20887787007408
948155H (20887787007408

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