# FDA recall Z-1063-2020

> **Centurion Medical Products Corporation** · Class II · device recall initiated 2019-12-11.

## Product

Centurion-LVAD Kits  DM1005	DAILY LVAD MAINTENANCE KIT  DM280A	LVAD MANAGEMENT SYSTEM 2-7  DM320	PERCUTANEOUS LEAD MANAGEMENT KIT  DM380	DAILY LVAD KIT MORRISTOWN MEDICAL  DM405A	ADVOCATE CHRIST DAILY WET KIT  DM405A	ADVOCATE CHRIST DAILY WET KIT  DM525	LVAD SENSITIVE KIT  DM545	U OF U LVAD SENSITIVE SKIN DRESSING SYST  DM550	VAD DRIVELINE MANAGEMENT TRAY  DM555	LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L  DM565	LVAD DRESSING SYSTEM  DM575	LVAD MULTI-DAY DRIVELINE MGMT SIZE S  DM610	DRIVELINE MANAGEMENT SYSTEM-DAILY  DM610	DRIVELINE MANAGEMENT SYSTEM-DAILY  DM610	DRIVELINE MANAGEMENT SYSTEM-DAILY  DM690	VAD DRIVELINE MANAGEMENT BUNDLE  DM710	VAD DAILY DRESSING CHANGE KIT  DM720	DAILY LVAD MAINTENANCE KIT  DM765	DAILY DRIVELINE MANAGEMENT SYSTEM  DM770	WEEKLY DRIVELINE MANAGEMENT SYSTEM  DM775	EXTENDED WEAR DRIVELINE MANAGEMENT KIT  DM775	EXTENDED WEAR DRIVELINE MANAGEMENT KIT  DM805	DAILY LVAD DRIVELINE MANAGEMENT SYSTEM  DM870	DAILY MAINTENANCE SYSTEM LVAD  DM920	GAUZE DRIVELINE MANAGEMENT

## Reason for recall

Incomplete seals on the sterile package may compromise the sterility

## Distribution

Nationwide  Foreign: GHANA

## Key facts

- **Recall number:** Z-1063-2020
- **Recalling firm:** Centurion Medical Products Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-11
- **Report date:** 2020-02-12
- **Termination date:** 2020-09-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Williamston, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2020

## Citation

> AI Analytics. FDA recall Z-1063-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-1063-2020. Source: US FDA. Licensed CC0.

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