FDA Enforcement
Class II
Terminated
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Recall: Z-0185-2014
·
Reported November 20, 2013
Enforcement
- Recall Number
- Z-0185-2014
- Event ID
- 65739
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 20, 2013
- Initiation Date
- August 29, 2013
- Classification Date
- November 8, 2013
- Termination Date
- February 11, 2021
- Address
- 920 Winter St, Waltham, MA, 02451-1521, United States
Description
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Reason
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Code Info
All lot codes
Distribution
Worldwide Distribution-USA (nationwide) and the country of Canada.
Quantity
24,202 cases