Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
- Company
- Maquet Cardiovascular, Llc
- Recall Initiated
- October 16, 2024
- Posted
- November 18, 2024
- Recall Number
- Z-0486-2025
- Quantity
- 33,823 units
- Firm Location
- Wayne, NJ
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.
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.
Lot / Code Info
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.
Root Cause
Process change control
Action Taken
MAQUET Cardiovascular LLC / Getinge notified consignees via letter FedEx 2-Day Delivery on 10/16/2024. Customers were instructed to forward the notification to all users and notify customers if further distributed, examine inventory and return any affected inventory, and to complete and return the MEDICAL DEVICE REMOVAL - RESPONSE FORM.