Z-2074-2014Class II

Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis

Name: Z-2074-2014 Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis
Creator: Baxter Healthcare Corp.
Published: 2014-06-17
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-06-17 / Terminated / root cause: packaging

FDA source

Baxter Healthcare Corp. began a recall of Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis on 2014-06-17. FDA classified it as Class II and gives the reason as "Inadequate iodine and packaging related defects". 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-2074-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-17
Posted: 2014-07-17
Terminated: 2015-04-03
Recalling firm: Baxter Healthcare Corporation
Product: Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Inadequate iodine and packaging related defects.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm notified their direct consignees on 06/17/2014 by letter requesting customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit.
Quantity in commerce: 585,360 units
Distribution: Distributed USA (nationwide) and Canada.
Product codes and lots: GD895771

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2074-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2074-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-23	2014-07-17

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)