Reported Nov 20, 2024 · Ongoing
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component:…
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
- A350XL Model/Catalog Number8621600
- Software VersionNot
- Applicable ComponentNot applicable
- Lot codes and dates
- Model/Catalog Number8621600
- UDI-DI Number04048675556183
- Serial Numbers Distributed in the US
304 of 304 codes
ASTA-030703090311034903500351035303630365039404080409 ASTB-0048028602870288028902900291030403050306030703080309031703180319032003210322 ASTC-000600070068006900700082008300990100010101050106010701080109011801190136013702290230024302440245 ASTD-00080009001000110012001300140129
- Serial Numbers Distributed OUS
137 of 137 codes
ASTA-025302890290032703620404040504260427042804290430 ASTB-000300050007002800290030003100320033007500760077007900800081008200830084013401950206021902200237 ASTC-0001000200030004002601380163018001810194ASTD-001500160050006100620063006400650066020302040205026502660267 ASTE-00340035
- Amount recalled
- 455 units (310 units US, 145 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
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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