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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
- Affected units
- 431
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
Part of a larger recall action
This product is one of 2 recalled by Draeger, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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