ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 25 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 (under-delivery of critical medication) could lead to serious adverse health consequences, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 25 units of REF: Z2850 112" (284 cm) 10 Drop Primary IV administration sets. 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.
The use of an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume, specifically under-delivery. This could lead to the under-delivery of critical medication, which may result in serious adverse health consequences for patients.
The affected product is identified by Lot number 4172062. The units were distributed to facilities in 44 U.S. states and Canada. Healthcare providers and consumers should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 25
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 number: 4172062
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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