The Recall Desk
SevereFDA (Devices)·Z-2799-2018·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

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4).

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 30 cm (12") PUR Bifuse Ext Sets with 3-Port NanoClave Manifold, Check Valve, 2 NanoClave, and Rotating Luer. These are single-use, sterile, non-pyrogenic devices 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 agency has classified this recall as Class II.

The affected lots are 3303902 (Expiration Date 08/01/2021) and 3380550 (Expiration Date 12/01/2021), with Item Number 011-AM3003. The distribution pattern includes US distribution to Arizona, Massachusetts, North Carolina, Ohio, Texas, Virginia, and Washington, as well as worldwide distribution to Belgium, France, and Germany. Users should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system.
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 011-AM3003. a. Lot Number 3303902
  • UDI Number (01)1 0840519 09277 6 (17)210800 (30) 50 (10) 3303902
  • Expiration Date 08/01/2021
  • b. Lot Number 3380550
  • UDI Number (01) 1 0840619 09277 8 (17) 211201 (30) 50(10) 3380550
  • Expiration Date 12/01/2021

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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Same hazard · leak

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