The Recall Desk
HighFDA (Devices)·Z-2815-2018·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 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 I.V. Administration Sets with NanoClave manifolds. The affected products are 10-inch smallbore extension sets featuring a 6-port NanoClave manifold, a NanoClave component, a check valve, a clamp, and a rotating luer.

The recall is being conducted due to the potential for the devices to develop a leak or for separation to occur between the female luer and the NanoClave manifold. The specific items involved are identified by Item Number AM6128 and include two specific lot numbers: 3423330 (Expiration Date 04/01/2022) and 3476737 (Expiration Date 06/01/2022).

The recall involves 150 pouches of the product. Distribution was limited to the United States (Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington) and worldwide to Belgium, France, and Germany. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), 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
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 Number AM6128. a. Lot Number 3423330
  • UDI Number (01) 1 0887709 08696 5 (17) 220401 (30) 50 (10) 3423330
  • Expiration Date 04/01/2022
  • b. Lot Number 3476737
  • UDI Number (01) 1 0887709 08696 5 (17) 220601 (30) 50 (10) 3476737
  • Expiration Date 06/01/2022

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

Same manufacturer · ICU Medical de Mexico, S.A. de C.V.

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Same hazard · leak

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