# FDA recall Z-1344-2021

> **Fenwal Inc** · Class II · device recall initiated 2021-02-25.

## Product

Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

## Reason for recall

Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs  during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a  blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

## Distribution

US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.

## Key facts

- **Recall number:** Z-1344-2021
- **Recalling firm:** Fenwal Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-25
- **Report date:** 2021-04-14
- **Termination date:** 2023-04-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2021

## Citation

> AI Analytics. FDA recall Z-1344-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1344-2021. Source: US FDA. Licensed CC0.

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