Z-1565-2013Class II

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

Name: Z-1565-2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended...
Creator: Baxter Healthcare Corp.
Published: 2013-05-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-05-21 / 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. Intended to isolate the Easy-Lock connector of the... on 2013-05-21. FDA classified it as Class II and gives the reason as "leaking pouches". 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-1565-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-21
Posted: 2013-06-21
Terminated: 2016-07-14
Recalling firm: Baxter Healthcare Corporation
Product: Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: leaking pouches
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837.
Quantity in commerce: 629,280 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number GD893891

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1565-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

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)