FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
- Recall number
- Z-0572-2022
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
- Status
- Open, Classified
- Initiated
- 2022-01-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
- Root cause
- Other
- Action
- Baxter disseminated a Urgent Medical Device Correction letter on 7 January 2022 to peritoneal dialysis centers and will follow with notice to the patients on 12 January 2022. The notices warned that the use of cleaning products and solvents may cause damage (for example, leaking or cracking), if they come into direct contact with the transfer set. Baxter will be updating the Instructions for Use (IFU) to include a warning against the use of these cleaning products and solvents. For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176.
- Quantity
- 344,190 units
- Distribution
- Worldwide
- Lot, serial or model codes
- All lot numbers within expiry
- 510(k) numbers
- ["K152675"]
- 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