Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Recall #Z-0486-2025 — Class II — October 16, 2024
Product Description
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Reason for Recall
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.
Recalling Firm
Maquet Cardiovascular, LLC — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
33,823 units
Distribution
Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.
Code Information
Model Number C-OM-10000Z. UDI-DI Number: 00607567100008. Batch Numbers: 3000277221, 3000286549, 3000315868, 3000317517, 3000322538, 3000339447, 3000363028, 3000270713, 3000275435, 3000275771, 3000280868, 3000284390, 3000303149, 3000321642, 3000342528, 3000336070, 3000322179, 3000337396, 3000273182, 3000282181, 3000337880, 3000353535, 3000364172, 3000357109, 3000276109, 3000338107, 3000354445, 3000355050, 3000352899, 3000324785, 3000360894, 3000370720, 3000323627, 3000346330, 3000356740, 3000278665, 3000344012, 3000366729, 3000361801, 3000400928, 3000363775, 3000311956, 3000343553, 3000367559, 3000377818, 3000341430, 3000367345, 3000336377, 3000316208, 3000381449, 3000380956, 3000403756, 3000321414, 3000361499, 3000407809, 3000398030, 3000387678, 3000320077, 3000277072, 3000283754, 3000296552, 3000320660, 3000339096, 3000347694, 3000348390, 3000352250, 3000279303, 3000277309, 3000282794, 3000283482, 3000350599, 3000351774, 3000351996, 3000365741, 3000369223, 3000369738, 3000393258, 3000323129, 3000273547, 3000366133, 3000391146, 3000273843, 3000280827, 3000295912, 3000346410, 3000401855, 3000384033, 3000382967, 3000378703, 3000363755, 3000316146, 3000295949, 3000398861, 3000394893, 3000380542, 3000361797, 3000350598, 3000320073, 3000299042, 3000295186, 3000288696, 3000284723, 3000274876, 3000363227, 3000285664.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated