Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Acrobati Positioner

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Acrobati Positionersee related information
Date Initiated by FirmOctober 16, 2024
Date PostedNovember 18, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0484-2025
Recall Event ID 95614
Product Classification Stabilizer, heart - Product Code MWS
ProductAcrobat-i Positioner. Model Number C-XP-5000Z
Code Information 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.
FEI Number 2242352
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactStephanie Moretti
973-709-7000
Manufacturer 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 2		Process change control
ActionMAQUET 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.
Quantity in Commerce14,338 units
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-