FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: MiniCap Extended Life PD Transfer Set
- Recall number
- Z-0768-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- MiniCap Extended Life PD Transfer Set
- Status
- Terminated
- Initiated
- 2020-11-10
- Posted
- not on file
- Terminated
- 2023-03-24
- Reason
- Potential for no-flow and leaks under the twist clamp.
- Root cause
- Process change control
- Action
- Urgent Medical Device Recall FA-2020-055 was sent to Peritoneal Dialysis Centers via U.S.P.S., first class mail on November 10, 2020. Urgent Medical Device Recall FA-2020-055 was sent via U.S.P.S., first class mail on November 13, 2020 to Home Patients who received impacted lots directly from Baxter. Out of an abundance of caution, Baxter will also be mailing the communication to all home patients who receive treatment at Peritoneal Dialysis Centers which received the impacted lots of transfer sets, regardless if the patient received the set or not.
- Quantity
- 72,771 units
- Distribution
- Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
- Lot, serial or model codes
- Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025
- 510(k) numbers
- ["K192705"]
- PMA numbers
- not on file
- Product code
- KDJ
- 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