FDA Medical Device Recalls (openFDA)
Gambro Renal Products, Inc.: Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
- Recall number
- Z-1861-2008
- Recalling firm
- Gambro Renal Products, Inc.
- Product
- Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
- Status
- Terminated
- Initiated
- 2008-05-02
- Posted
- 2008-09-26
- Terminated
- 2012-05-22
- Reason
- Dialysis tubing sets may have occlusions restricting blood flow.
- Root cause
- Process control
- Action
- Customers were sent an "Urgent Product Safety Notice" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an "Urgent Product Recall" letter was sent to all customers requesting the return of all remaining affected blood sets.
- Quantity
- not on file
- Distribution
- Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
- Lot, serial or model codes
- Serial numbers: 0XP15XXXX (all lots)
- 510(k) numbers
- ["K070414"]
- PMA numbers
- not on file
- Product code
- FJK
- Firm FEI
- 1713683
- Firm city
- Lakewood
- Firm state
- CO
- 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