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FDA (Device enforcement)Recalled 2025-04-07class i

Baxter Healthcare Corporation: 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) RMS010

Hazard

A cybersecurity vulnerability was discovered through internal testing.

Details from the source

Reason for recall: A cybersecurity vulnerability was discovered through internal testing. Distribution: Worldwide distribution. Quantity: 4881 units Lot/code info: 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.

UPC codes

00815410020537, 00887761978089, 00815410020278

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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