FDA Medical Device Recalls (openFDA)
Fresenius Medical Care North America: CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
- Recall number
- Z-0859-2009
- Recalling firm
- Fresenius Medical Care North America
- Product
- CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device
- Status
- Terminated
- Initiated
- 2008-11-25
- Posted
- 2009-01-23
- Terminated
- 2009-09-24
- Reason
- Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- Root cause
- Process control
- Action
- Fresenius Medical contacted customers by e-mail,telephone and hard copy letter advising users to immediately discontinue use and return inventory. All internal customers were emailed on 11/25/08. All external customers were US Certified Mailed on 11/26/08. All internal customers were US Certified Mailed on 12/2/08 & 12/3/08.
- Quantity
- 57 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Lot, serial or model codes
- Lot number 8LR902 only
- 510(k) numbers
- ["K022536"]
- PMA numbers
- not on file
- Product code
- KOC
- Firm FEI
- 3001451489
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28