ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error
ICU Medical is recalling specific IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking inaccurate medication delivery.
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 source text states the error 'may lead to serious adverse health consequences,' but no injuries or illnesses have been reported.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of 121-inch 10 Drop Primary IV Administration Sets. The recall involves 4,800 units distributed across 44 US states and Canada. The affected product is identified by Reference Z2812 and includes specific lot numbers 4168876, 4168877, 4169640, and 4169641.
The recall is due to a potential manufacturing error where the sets may contain a 15 drops/mL drop cannula instead of the intended 10 drops/mL drop cannula within the drip chamber. This discrepancy could result in the inaccurate delivery of the intended infusion volume, specifically leading to under-delivery of critical medication.
Under-delivery of critical medication may lead to serious adverse health consequences for patients. The source text does not report any specific illnesses or injuries associated with this recall. Healthcare facilities and consumers should check their inventory for the specific lot numbers and reference numbers listed and stop using the affected sets.
The recalled product
- Product
- REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 4,800
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 numbers: 4168876
- 4168877 4169640
- 4169641
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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