ICU Medical Recalls I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of I.V. Administration Sets with NanoClave manifolds due to potential leaks or separation between the female luer and the manifold.
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 the hazard involves a structural defect (leak/separation) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
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 PROXIMALE 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer. The recall involves 30 pouches with Item Number 011-AM6129, Lot Number 3459160, and an expiration date of 05/01/2022.
The recall is being conducted due to the potential for the product to develop a leak or for separation to occur between the female luer and the NanoClave manifold. This defect could compromise the integrity of the intravenous administration system.
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 lots and contact the manufacturer for further instructions.
The recalled product
- Product
- PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
- Manufacturer
- ICU Medical de Mexico, S.A. de C.V.
- Hazard
- Affected units
- 30
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 Number011-AM6129. Lot Number 3459160
- UDI Number (01) 1 0840619 09605 2 (17) 220501 (30) 01 (10) 3459160
- Expiration Date 05/01/2022
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
- HighICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
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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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