FDA Enforcement Class II Ongoing

Welch Allyn CONNEX Accessory Power Management Stand:

Recall: Z-1559-2025 · Reported April 23, 2025

Enforcement

Recall Number
Z-1559-2025
Event ID
96478
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
April 23, 2025
Initiation Date
March 24, 2025
Classification Date
April 14, 2025
Address
1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

Description

Welch Allyn CONNEX Accessory Power Management Stand:

Reason

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

Code Info

All Serial Numbers. Product Code: 7000-APM, UDI-DI: 00732094210613; Product Code: 75-HCA-CTB, UDI-DI: 00732094240597; Product Code: 75-HCA-MTB, UDI-DI: 00732094240603;

Distribution

Worldwide - US Nationwide distribution.

Quantity

114,202 units