ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with inline filters because they may leak fluid from air vents. The affected units were 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 recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric, as it involves a risk of temporary or medically reversible health consequences.
Plain-English summary
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters, specifically the Sapphire Epidural Set Yellow-Striped Microbore with 0.2 Micron Filter. The recall involves 6,516 units of the product, which are packaged as 1 unit per blister and 40 blisters per case. The affected lot numbers are 855735H, 866165H, 897465H, 907305H, 929285H, and 929425H, under product code 163639255.
The recall was initiated due to a potential for fluid leakage out of the air vents on the inline filters. This defect could compromise the integrity of the infusion system during use. The agency has classified this as a Class II recall, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The affected products were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. They were also distributed internationally to 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 providers and facilities should check their inventory for these specific lot numbers and stop using the affected infusion sets immediately.
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 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
- Manufacturer
- ICU Medical Inc
- Hazard
- Affected units
- 6,516
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: 163639255
- Lot number 855735H
- 866165H
- 897465H
- 907305H
- 929285H
- 929425H
Distribution
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.
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