Recall Z-0484-2025
Maquet Cardiovascular, LLC · initiated October 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Acrobat-i Positioner. Model Number C-XP-5000Z
Codes / lots: Model Number C-XP-5000Z. UDI-DI Number: 00607567500006. Batch Numbers: 3000272452, 3000289270, 3000293675, 3000340401, 3000382289, 3000282355, 3000287205, 3000290368, 3000306921, 3000308238, 3000307458, 3000318694, 3000282741, 3000290350, 3000306394, 3000334128, 3000355318, 3000362345, 3000278266, 3000343467, 3000353846, 3000346421, 3000360292, 3000364706, 3000317546, 3000272461, 3000343116, 3000360175, 3000360569, 3000355540, 3000380141, 3000378810, 3000334322, 3000363049, 3000311731, 3000306920, 3000365139, 3000273855, 3000300092, 3000276339, 3000347351, 3000347358, 3000352249, 3000397151, 3000368288, 3000293958, 3000288356, 3000286557, 3000402809, 3000392590, 3000340972.
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.
FDA-determined 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.
Details
- Recall number
- Z-0484-2025
- Initiated
- October 16, 2024
- Posted by FDA
- November 18, 2024
- Product code
- MWS – Stabilizer, Heart
- Quantity
- 14,338 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…
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0485-2025 Class II | Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility… | 10/16/2024Open, Classified |
| Z-0486-2025 Class II | Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000ZDeviations in the manufacturing process created a compromise in the sterile barrier, in which sterility… | 10/16/2024Open, Classified |