CLASS I ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report

Life2000 Ventilator PKG, Hospital, a) recalled by Baxter Healthcare

Baxter Healthcare is recalling Life2000 Ventilator PKG, Hospital, a), distributed nationwide in the US. The recall was initiated on 25 Jan 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015

Quantity recalled8 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1141-2023
FDA event ID: 91506
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 25 Jan 2023
FDA classified: 24 Feb 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

25 Jan 2023	Recall initiated by company
24 Feb 2023	Classified by FDA	+30 days
8 Mar 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Product as listed by the FDA

Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals

Where it was distributed

Nationwide

Questions about this recall

Is Life2000 Ventilator PKG, Hospital, a) recalled?

Yes. Baxter Healthcare recalled Life2000 Ventilator PKG, Hospital, a) on 25 Jan 2023. The recall is Class I and its status is Ongoing. Recall number Z-1141-2023.

Why was it recalled?

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

Which lots are affected?

a) REF BT200011, UDI 00887761978089, Serial Numbers: L190606-014, L191011-040, L200127-015, L200204-013; b) REF BT-20-0011, UDI 00887761978089, Serial Numbers: L200226-012, L200226-013, L200226-015

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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