The Recall Desk
HighFDA (Devices)·Z-2797-2018·Announced 2018-08-22

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 is classified as FDA Class II. The hazard involves a potential leak or separation in a medical device used for vascular access, which presents a risk of harm, 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 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.

The affected product is the 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. This is a single-use, sterile, non-pyrogenic device used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers 81 pouches of Item Number 011-AM3002, specifically Lot Number 3326545 (Expiration Date 09/01/2021) and Lot Number 3459161 (Expiration Date 05/01/2022).

The affected units 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. The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.

The recalled product

Product
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system.
Manufacturer
ICU Medical de Mexico, S.A. de C.V.
Category
Medical Device — I.V. Administration Sets
Hazard
Affected units
81

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-AM3002. a. Lot Number 3326545
  • UDI Number (01) 1 0640619 09275 4 (17) 210901 (30) 50 (10) 3326545
  • Expiration Date 09/01/2021
  • b. Lot Number 3459161
  • UDI Number (01) 1 0840619 09275 4 (17) 220501 (30) 50 (10) 3459161
  • 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 →

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