Z-1945-2014Class II

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis

Name: Z-1945-2014 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis
Creator: Baxter Healthcare Corp.
Published: 2013-07-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-07-08 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis on 2013-07-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1945-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2014-06-30
Terminated: 2014-06-30
Recalling firm: Baxter Healthcare Corporation
Product: Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 20,940 units
Distribution: Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
Product codes and lots: Lot Numbers: GD894535, GD894550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1945-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1945-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-30

Product code KDI

K895631Class IIDisconnect Caps Product Codes 5C4212 and 5C4466Baxter Healthcare Corp / cleared 1990-01-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)