The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2800-2018·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 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 potential for leak or separation, which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

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 affected is the DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap. 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 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 recall includes 122 pouches of the product, identified by Item Number 011-AM3006, Lot Number 3508532, and Expiration Date 08/01/2022.

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. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of…
Manufacturer
ICU Medical de Mexico, S.A. de C.V.
Category
Medical Device — I.V. Administration Sets
Hazard
Affected units
122

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 (3)

  • Item Number 011-AM3006. Lot Number 3508532
  • UDI Number (01) 1 0840619 09320 1 (17) 220601 (30) 20 (10) 3508532
  • Expiration Date 08/01/2022

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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