ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall for I.V. Administration Sets with NanoClave manifolds due to potential leaks or component separation.
What this means for you
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 is classified as FDA Class II and involves a risk of harm (leak/separation) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical de Mexico, S.A. de C.V. is expanding the scope of a previously initiated recall to include additional I.V. Administration Sets with NanoClave manifolds. The specific product affected is the 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer. The recall involves 100 pouches of Item Number 011-AM3011, Lot Number 3408988, with an expiration date of 02/01/2022.
The recall is being conducted due to the potential for the device to develop a leak or for separation to occur between the female luer and the NanoClave manifold. This is classified as a Class II recall by the U.S. Food and Drug Administration.
The affected products were distributed in the United States to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington. Additionally, the products were distributed worldwide to Belgium, France, and Germany. Healthcare facilities and consumers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
- Manufacturer
- ICU Medical de Mexico, S.A. de C.V.
- Hazard
- Affected units
- 100
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 (3)
- Item Number 011-AM3011. Lot Number 3408988
- UDI Number (01) 1 0840619 09531 1 (17) 220201 (30) 50 (10) 3408988
- Expiration Date 02/01/2022
Distribution
Part of a larger recall action
This product is one of 20 recalled by ICU Medical de Mexico, S.A. de C.V. 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 20 products in this recall →Related recalls
Same manufacturer · ICU Medical de Mexico, S.A. de C.V.
See all →- HighICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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- HighICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
- HighICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
- HighICU Medical Recalls I.V. Administration Sets Due to Leak Risk
FDA (Devices) · 2018-08-22
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