Reported Dec 25, 2024 · Ongoing
Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation…
Draeger Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Brand NameAtlan
- Product NameAtlan
- A300XL Model/Catalog Number8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates
- Lot codes and dates
- Model/Catalog Number8621400
- UDI-DI Number04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co
- KGaA to OUS
ASTB-00510053005400550063006500930162 ASTE-02190220022102220377 ASTF-04720473 ASTH-000500060026002700470186022302240401 ASTJ-0170
- Amount recalled
- 25 units (OUS Only)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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