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 involves a medical device with a structural defect (leak/separation) that poses a risk of harm, 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 specific product involved is the Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear, Item Number 011-AM6123.
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 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, as well as worldwide to Belgium, France, and Germany. The recall includes 302 pouches from Lot Number 3393136 (Expiration Date 11/01/2022) and Lot Number 3508527 (Expiration Date 08/01/2022). Healthcare facilities and consumers should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
- Manufacturer
- ICU Medical de Mexico, S.A. de C.V.
- Hazard
- Affected units
- 302
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 (6)
- Item Number 011-AM6123. a. Lot Number 3393136
- UDI Number (01) 1 0840619 09404 8 (17) 220101 (30) 20 (10) 3393136
- Expiration Date 11/01/2022
- b. Lot Number 3508527
- UDI Number (01) 1 0840619 09404 8 (17) 220801 (30) 20 (10) 3508527
- 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
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