The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2814-2018·Announced 2018-08-22

ICU Medical Recalls I.V. Administration Sets with NanoClave Manifold

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 or 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 affected products are 11-inch Smallbore Extension Sets featuring a 6-Port NanoClave Manifold, Check Valve, Clamp, and Rotating Luer. The recall covers 100 pouches of Item Number AM6127.

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. 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. The specific lots involved are Lot Number 3379607 (Expiration Date 12/01/2021) and Lot Number 3436226 (Expiration Date 04/01/2022). Consumers and healthcare providers should stop using these specific products and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.
Manufacturer
ICU Medical de Mexico, S.A. de C.V.
Category
Medical Device — I.V. Administration Sets
Hazard
Affected units
100

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 AM6127. a. Lot Number 3379607
  • UDI Number (01) 1 0887709 08635 4 (17) 211201 (30) 50 (10) 3379607
  • Expiration Date 12/01/2021
  • b. Lot Number 3436226
  • UDI Number (01) 1 0887709 08635 4 (17) 220401 (30) 50 (10) 3436226
  • Expiration Date 04/01/2022

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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