Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-300
FDA device recall Z-0132-2015 · posted 2014-10-24 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.
- Action taken
- Maquet Inc. issued Recall letters/Acknowledgement forms dated via Fed-Ex on 8/13/2014.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MWS
- Quantity affected
- 16,532 units (19,270 units international)
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: ARGENTINA, AUSTRIA, BANGLADESH, BELARUS, BRAZIL, BRUNEI, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, GERMANY, F
- Date initiated
- 2014-08-13
- Date posted
- 2014-10-24
- Date terminated
- 2016-03-30
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.