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