The Recall Desk
HighFDA (Devices)·Z-2808-2018·Announced 2018-08-22

ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

ICU Medical is expanding a recall of 150 pouches of smallbore 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 risk of harm (leak or separation) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

ICU Medical de Mexico, S.A. de C.V. is expanding the scope of a previously initiated recall to include additional 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer. The recall involves 150 pouches of these I.V. administration sets.

The recall is being conducted due to the potential for the product to develop a leak or for separation between the female luer and the NanoClave manifold. The affected products are identified by Item Number 011-AM6126 and include Lot Number 3409000 (Expiration Date 02/01/2022) and Lot Number 3446970 (Expiration Date 05/01/2022).

The 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 source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items.

The recalled product

Product
40 cm (16") Smallbore Ext Set w/6-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.
Category
Medical Device — I.V. Administration Sets
Hazard
Affected units
150

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 Number011-AM6126. a. Lot Number 3409000
  • UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10) 3409000
  • Expiration Date 02/01/2022
  • b. Lot Number 3446970
  • UDI Number (01) 1 0840619 09534 2 (17) 220201 (30) 50 (10)3446970
  • Expiration Date 05/01/2022

Distribution

Distributed in 7 states:

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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Same hazard · leak

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