ICU Medical Recalls I.V. Administration Sets Due to Leak Risk

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

• leak
• separation

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.

Distribution

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