The Recall Desk
ModerateFDA (Devices)·Z-0980-2017·Announced 2017-01-18

ICU Medical Recalls 24-Hour Primary Sets with Incorrect Drip Chambers

ICU Medical is recalling 225 units of 24-hour primary sets where a 15-drop drip chamber was installed instead of the required 60-drop chamber.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source describes an isolated assembly error without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ICU Medical, Inc. is recalling 225 units of 133" 60 Drop 24 Hour Primary Sets, Item No. B59006. The recall involves an isolated event where a 15 drop drip chamber was assembled on a device that should contain a 60 drop drip chamber.

The affected product is a single-use, sterile, non-pyrogenic intravascular administration set used to provide access for the administration of fluids from a container to a patient's vascular system. The specific lot number is 3323650. The distribution pattern for these units is North Carolina (NC).

The source text does not specify the exact action consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with this event.

The recalled product

Product
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a containe
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard
Affected units
225

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 No. 3323650

Distribution

Distributed in 1 state:

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