ICU Medical Recalls 3 Port Off Manifold Due to Component Commingling
ICU Medical is recalling 60 units of a 3 Port Off Manifold waste system because a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
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 text describes a potential component comingling without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
ICU Medical, Inc. has initiated a recall of 60 units of the 3 Port "Off" Manifold w/Waste Bag, Syringe and DyePod waste system. The specific product affected is identified by Part Number AG8049-NS and Lot # 2528655. The recall is limited to distribution in Virginia.
The recall was issued because the company identified a potential comingling of components. Specifically, a 60 drop micro drip chamber may have been included on a 20 drop macro drip set. This discrepancy could affect the intended function of the medical device.
Healthcare facilities and consumers who possess this specific lot of the product should stop using it and contact ICU Medical, Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Waste System
- Hazard
- Affected units
- 60
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 (2)
- Part Number (Item #) AG8049-NS
- Lot # 2528655.
Distribution
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