ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues
ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller 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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the defect involves a significant deviation in flow rate for a medical device, posing a risk of serious injury.
Plain-English summary
ICU Medical, Inc. is recalling 1,150 units of 98-inch (249 cm) primary IV administration sets, Item No. Z2648. These devices are intended for the infusion and withdrawal of fluids and are provided sterile. The specific units affected are identified by lot numbers 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, and 36-469-SL.
The recall was initiated because the ConMed Stat 2 flow controller included in these sets may deliver a significantly higher flow rate than was intended. This defect could result in the administration of fluids at unsafe speeds.
The affected products were distributed worldwide, specifically in the United States (nationwide, with specific mentions of Washington and Oregon) and South Africa. Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected devices immediately.
The recalled product
- Product
- 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,150
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)
- Lot # 34-128-HE
- 34-540-Y1
- 35-151-SJ
- 35-805-JW
- 36-137-SL
- 36-469-SL
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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