Z-1725-2025 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
May 21, 2025
Initiation Date
April 7, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4881 units

Product Description

Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.

Reason for Recall

A cybersecurity vulnerability was discovered through internal testing.

Distribution Pattern

Worldwide distribution.

Code Information

ALL SERIAL NUMBERS: 1) BT-20-0002, UDI/DI 00815410020537 or 00887761978089; 2) BT-20-0002A, UDI/DI 00815410020537 of 00887761978089; 3) BT-20-0002AP, UDI/DI 00815410020537 or 00887761978089; 4) BT200007, UDI/DI 00815410020278 or 00887761978089; 5) BT-20-0007, UDI/DI 00815410020278 or 00887761978089; 6) BT200011, UDI/DI 00815410020537 or 00887761978089; 7) BT-20-0011, UDI/DI 00815410020537 or 00887761978089; 8) RMS010118CP, UDI/DI 00815410020537 or 00887761978089.