The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2812-2018·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 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 involves 200 pouches of the 10" Smallbore Ext Set w/6-Port NanoClave Manifold, which features orange, red, blue, purple, and yellow rings, a check valve, a clamp, and a rotating luer.

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. The affected products are identified by Item Number AM6100 and include three specific lot numbers: 3373756 (Expiration Date 12/01/2021), 3423328 (Expiration Date 04/01/2022), and 3446319 (Expiration Date 05/01/2022).

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 facilities should check their inventory for these specific lot numbers and discontinue use if found.

The recalled product

Product
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), 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
200

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 (9)

  • Item Number AM6100. a. Lot Number 3373756
  • UDI Number (01) 1 0887709 07066 7 (17) 211201 (30) 50 (10) 3373756
  • Expiration Date 12/01/2021
  • b. Lot Number 3423328
  • UDI Number (01) 1 0887709 07066 7 (17) 211401 (30) 50 (10) 3423328
  • Expiration Date 04/01/2022
  • c. Lot Number 3446319
  • UDI Number (01) 1 0887709 07066 7 (17) 211501 (30) 50 (10) 3446319
  • 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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