ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
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 source text explicitly states that the defect 'may lead to serious adverse health consequences,' which aligns with the rubric criterion for Severe (4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
ICU Medical, Inc. is recalling 14,000 units of IV administration sets (REF: B90240-50) due to a potential manufacturing error. The affected sets may contain a 15 drops/mL drop cannula within the drip chamber instead of the intended 10 drops/mL drop cannula.
The use of an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume, specifically under-delivery. This under-delivery of critical medication may lead to serious adverse health consequences for patients.
The recalled product was distributed in the United States and Canada. Affected lot numbers are 4168837, 4169606, and 4168835. Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected sets.
The recalled product
- Product
- REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 14,000
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)
- Lot #: 4168837
- 4169606
- 4168835
Distribution
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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- SevereICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
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- SevereICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
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