FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Recall number
- Z-1684-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
- Status
- Terminated
- Initiated
- 2021-04-14
- Posted
- not on file
- Terminated
- 2024-05-10
- Reason
- There is a potential leak between the venous patient connector and patient's hemodialysis access.
- Root cause
- Under Investigation by firm
- Action
- An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email.
- Quantity
- 17,487 units
- Distribution
- Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
- Lot, serial or model codes
- Product Code: 101025; Lot 1000276191, UDI: 37332414007837
- 510(k) numbers
- ["K070414"]
- PMA numbers
- not on file
- Product code
- FJK
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- 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