ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 650 units of 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the hazard is under-delivery of critical medication leading to serious adverse health consequences, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 650 units of REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp. The affected lot numbers are 4172061 and 4173149. The recall is due to a potential manufacturing error where the IV administration 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 error could lead to the under-delivery of critical medication, which may result in serious adverse health consequences for patients.
The affected products were distributed to 48 states in the United States and Canada. The source text notes that REF numbers AH7117 and B30211 were not marketed or distributed within the US. Healthcare facilities and consumers should stop using the affected units and contact ICU Medical for further instructions.
The recalled product
- Product
- REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 650
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 numbers: 4172061 and 4173149
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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