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 luer and 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 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, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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 affected product is the 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer (Item Number AM6130). The recall involves 300 pouches distributed in the United States to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington, as well as to Belgium, France, and Germany.
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. Specific lot numbers affected include 3414534, 3442461, and 3509517, with expiration dates ranging from February 2022 to August 2022.
Healthcare facilities and consumers should stop using the affected I.V. Administration Sets and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- 6" 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
- 300
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 AM6130. a. Lot Number 3414534
- UDI Number (01) 1 0887709 08771 9 (17) 220201 (30) 50 (10) 3414534
- Expiration Date 02/01/2022
- b. Lot Number 3442461
- UDI Number (01) 1 0887709 08771 9 (17) 220501 (30) 50 (10) 3442461
- Expiration Date 05/01/2022
- b. Lot Number 3509517
- UDI Number (01) 1 0887709 08771 9 (17) 220801 (30) 50 (10) 3509517
- 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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