# FDA recall Z-2621-2018

> **ICU Medical, Inc.** · Class II · device recall initiated 2017-07-31.

## Product

140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile    The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

## Reason for recall

Some devices were labeled as  Does not contain DEHP  even though the product may contain small amounts of DEHP.

## Distribution

Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and  South Africa.

## Key facts

- **Recall number:** Z-2621-2018
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-31
- **Report date:** 2018-08-15
- **Termination date:** 2019-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2018

## Citation

> AI Analytics. FDA recall Z-2621-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2621-2018. Source: US FDA. Licensed CC0.

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