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 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 involves a medical device with a potential for leak or separation, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
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 recall involves 650 pouches of the 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer (Item Number AM6109). The affected lots are 3373758, 3391364, and 3511445, with expiration dates ranging from December 2021 to August 2022.
The recall is being conducted because the devices have the potential 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 these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
- Manufacturer
- ICU Medical de Mexico, S.A. de C.V.
- Hazard
- Affected units
- 650
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 (9)
- Item Number AM6109. a. Lot Number 3373758
- UDI Number (01) 1 0887709 07764 2
- Expiration Date 12/01/2021
- b. Lot Number 3391364
- UDI Number (01) 1 0887709 07764 2 (17) 220101 (30) 50 (10) 3391364
- Expiration Date 01/01/2022
- c. Lot Number 3511445
- UDI Number (01) 1 0887709 07764 2 (17) 220801 (30) 50 (10) 3511445
- Expiration Date 08/01/2022
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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