medical Class II Updated 2024-11-27

Maquet Cardiovascular, LLC recalls Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-

Recalled Product

Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z


Hazard / Issue

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number C-OM-9000Z. UDI-DI Number: 00607567900004. Batch Numbers: 3000270477, 3000274130, 3000279333, 3000325028, 3000349295, 3000356305, 3000368568, 3000288446, 3000314841, 3000318197, 3000340989, 3000315179, 3000284660, 3000279342, 3000325025, 3000340964, 3000274640, 3000280059, 3000280563, 3000325362, 3000284695, 3000314838, 3000349055, 3000356063, 3000298982, 3000317739, 3000376711, 3000279839, 3000399170, 3000362853, 3000337154, 3000321412, 3000299814, 3000288445, 3000269996.
View official government recall

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