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.
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 2/5 (Moderate).
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…
- Manufacturer
- ICU Medical, Inc.
- 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:
Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · mis assembly
See all →- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighGuidewire for Hemodialysis Catheters Recalled Due to Incorrect Assembly
FDA (Devices) · 2024-09-18
- CriticalEdwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error
FDA (Devices) · 2019-02-06
- LowArthrex Suture Washer Recalled Due to Incorrect Assembly
FDA (Devices) · 2016-10-12
- SevereGE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings
FDA (Devices) · 2014-03-05
Similar recalls
- HighICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
FDA (Devices) · 2020-05-13
- SevereICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
FDA (Devices) · 2020-05-13
- HighICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
FDA (Devices) · 2021-02-17
- HighICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error
FDA (Devices) · 2020-05-13
- HighICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
FDA (Devices) · 2020-10-28