Vapor 2000 anesthetic vaporizers recalled over an out of specification component
Draeger is recalling 431 Vapor 2000 anesthetic vaporizers because a certain component was not delivered within specification and contained impurities. The action is Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Draeger Vapor 2000, an unheated calibrated anesthetic vaporizer, model M35054, is being recalled.
A certain component of affected devices was not delivered within specification and contained impurities.
The record lists 431 units carrying UDI-DI 04048675228059, with serial numbers listed in the enforcement record including ASUK-0421 through ASUK-0425. Distribution was worldwide, including nationwide in the United States across Alaska, California, Florida, Iowa, Kansas, Maryland, Maine, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, South Dakota and Tennessee. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock immediately and follow Draeger's instructions.
The recalled product
- Product
- Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
- Manufacturer
- Draeger, Inc.
- Hazard
- out-of-specification
- impurities
- anesthesia
- class-i
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. M35054
- UDI-DI: 04048675228059
- Serial No. ASUK-0421
- ASUK-0422
- ASUK-0423
- ASUK-0424
- ASUK-0425
- ASUK-0426
- ASUK-0602
- ASUK-0603
- ASUK-0705
- ASUK-0706
- ASUK-0707
- ASUK-0708
- ASUK-0721
- ASUK-0722
- ASUK-0723
- ASUK-0724
- ASUK-0725
- ASUK-0726
Distribution
Distributed nationwide across the United States.
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