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: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device
- Recall number
- Z-0860-2009
- 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: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and 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
- 351,743 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Lot, serial or model codes
- Lot Numbers: 8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271.
- 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