ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk
ICU Medical is recalling 100 units of ConMed Stat 2 flow controllers because they may deliver a significantly higher flow rate than intended.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended."
Plain-English summary
ICU Medical, Inc. is recalling 100 units of the ConMed Stat 2 flow controller, Item No. B9897. The product is an 83-inch (211 cm) primary IV administration set with a rotating luer, provided sterile for the infusion and withdrawal of fluids.
The recall was initiated because the flow controller may deliver a significantly higher flow rate than was intended. This defect could result in the administration of fluids at unsafe speeds.
The affected units are from Lot # 2801951. Distribution was worldwide, specifically in the United States (nationwide, with specific mentions of Washington and Oregon) and South Africa. Healthcare providers and consumers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 100
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 (1)
- Lot # 2801951
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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