ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 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 explicitly states that the defect 'may lead to serious adverse health consequences,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk scenarios warranting a Severe rating.
Plain-English summary
ICU Medical, Inc. is recalling 1,000 units of IV administration sets (REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211). The recall was initiated because the sets may contain a 15 drops/mL drop cannula instead of the intended 10 drops/mL drop cannula within the drip chamber.
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 affected product was distributed in the United States (excluding specific states listed in the source) and Canada. The source notes that REF numbers AH7117 and B30211 were not marketed or distributed within the US, and Lot # 4168832 was not distributed within the US. Healthcare providers and consumers should check their inventory for this specific product and discontinue use if found.
The recalled product
- Product
- REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,000
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 (1)
- Lot # 4168832 *Product not distributed within the US
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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Same hazard · medication under delivery
See all →- HighInfusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
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- HighICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
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- SevereICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula
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- SevereICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
FDA (Devices) · 2020-05-13
- SevereICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
FDA (Devices) · 2020-05-13
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