Reported Apr 4, 2018 · Terminated
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
- Lot codes and dates
- Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187
- Amount recalled
- 2
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
Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.
This product could cause temporary or reversible health problems — stop using it.
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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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