FDA Medical Device Recalls (openFDA)
Fresenius Medical Care Holdings, Inc.: Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
- Recall number
- Z-0844-2011
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Product
- Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
- Status
- Terminated
- Initiated
- 2010-11-19
- Posted
- 2011-01-10
- Terminated
- 2012-11-03
- Reason
- Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
- Root cause
- Device Design
- Action
- Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.
- Quantity
- 10, 032 units (418 cases x 24 units)
- Distribution
- Distribution Nationwide and Canada
- Lot, serial or model codes
- Lots 09JR01174, 09JR01229, 09NR01139, 10KR01801
- 510(k) numbers
- ["K962081"]
- PMA numbers
- not on file
- Product code
- FJK
- 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