ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.
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 injury has not yet been reported, but the potential for under-delivery of critical medication could lead to serious adverse health consequences.
Plain-English summary
ICU Medical, Inc. is recalling 275 units of REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R (Lot 4169647). The recall is due to a potential defect 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 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 units were distributed to 48 US states and Canada. Consumers and healthcare facilities should stop using the affected IV administration sets and contact ICU Medical, Inc. for further instructions or replacement.
The recalled product
- Product
- REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 275
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: 4169647
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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