# FDA recall Z-2107-2020

> **Quest Medical, Inc.** · Class II · device recall initiated 2019-12-17.

## Product

Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI:  (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135  (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

## Reason for recall

Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed.  This could lead to over delivery of potassium by the user requiring medical intervention.

## Distribution

US Nationwide distribution including in the states of  NY, PA, TN, WV. OUS:  None

## Key facts

- **Recall number:** Z-2107-2020
- **Recalling firm:** Quest Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-17
- **Report date:** 2020-06-03
- **Termination date:** 2024-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allen, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2020

## Citation

> AI Analytics. FDA recall Z-2107-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2107-2020. Source: US FDA. Licensed CC0.

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