FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
- Recall number
- Z-1945-2014
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
- Status
- Terminated
- Initiated
- 2013-07-08
- Posted
- 2014-06-30
- Terminated
- 2014-06-30
- Reason
- the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
- Root cause
- Packaging change control
- Action
- An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.
- Quantity
- 20,940 units
- Distribution
- Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
- Lot, serial or model codes
- Lot Numbers: GD894535, GD894550
- 510(k) numbers
- ["K895631"]
- PMA numbers
- not on file
- Product code
- KDI
- 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