# FDA recall Z-2815-2018

> **ICU Medical de Mexico, S.A. de C.V.** · Class II · device recall initiated 2018-03-01.

## 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.

## Reason for recall

ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.

## Distribution

US distribution to AZ, MA, NC, OH, TX, VA, WA.      Worldwide distribution to Belgium, France, Germany.

## Key facts

- **Recall number:** Z-2815-2018
- **Recalling firm:** ICU Medical de Mexico, S.A. de C.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-01
- **Report date:** 2018-08-22
- **Termination date:** 2024-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ejido Maneadero, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2815-2018

## Citation

> AI Analytics. FDA recall Z-2815-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2815-2018. Source: US FDA. Licensed CC0.

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