# FDA recall Z-0069-2019

> **ICU Medical, Inc.** · Class II · device recall initiated 2018-08-20.

## Product

ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28     The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

## Reason for recall

Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.

## Distribution

U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.

## Key facts

- **Recall number:** Z-0069-2019
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-08-20
- **Report date:** 2018-10-10

- **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-0069-2019

## Citation

> AI Analytics. FDA recall Z-0069-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0069-2019. Source: US FDA. Licensed CC0.

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