Acrobat-i Vacuum Stabilizer System Recalled for Sterile Barrier Compromise
Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with a compromised sterile barrier. Although no illnesses or injuries have been reported, the device's inability to maintain sterility throughout its 2-year shelf life poses an inherent risk of infection in the surgical setting, meeting the criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Acrobat-i Vacuum Stabilizer System, Model C-OM-10000Z. Approximately 33,823 units have been distributed nationwide and internationally to 30 additional countries.
Manufacturing process deviations compromised the sterile barrier of the device. As a result, sterility cannot be assured during the product's 2-year shelf life.
The affected devices can be identified by model number C-OM-10000Z and UDI-DI number 00607567100008. Affected batch numbers are available from the FDA.
The recalled product
- Product
- Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- sterile-barrier-compromise
- infection-risk
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)
- 3000286549
- 3000315868
- 3000317517
- 3000322538
- 3000339447
- 3000363028
- 3000270713
- 3000275435
- 3000275771
- 3000280868
- 3000284390
- 3000303149
- 3000321642
- 3000342528
- 3000336070
- 3000322179
- 3000337396
- 3000273182
- 3000282181
- 3000337880
Distribution
Distributed nationwide across the United States.
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