2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
This recall has been terminated (originally issued November 8, 2013).
- Recall Initiated
- August 29, 2013
- Posted
- November 8, 2013
- Terminated
- February 11, 2021
- Recall Number
- Z-0184-2014
- Quantity
- 8,528 cases
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
Distribution
Worldwide Distribution-USA (nationwide) and the country of Canada.
Lot / Code Info
All lot codes
Root Cause
Labeling design
Action Taken
Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.