Z-1269-2015Class II

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis

Name: Z-1269-2015 MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis
Creator: Baxter Healthcare Corp.
Published: 2015-01-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2015-01-22 / Completed

FDA source

Baxter Healthcare Corp. began a recall of MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis on 2015-01-22. FDA classified it as Class II and gives the reason as "Product may have separating or protruding sponges". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1269-2015
Classification: Class II
Status: Completed
Initiated: 2015-01-22
Posted: 2015-03-13
Recalling firm: Baxter Healthcare Corporation
Product: MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Product may have separating or protruding sponges
FDA root cause: Under Investigation by firm
Action: Baxter sent an Urgent Product Recall letter dated January 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. If you received your product directly from Baxter, please complete the enclosed customer reply form, and return it to Baxter by either fax or scanned e-mail. 1. If you ordered product from a dealer, wholesaler, or distributor/reseller, please follow your supplier's reply and recall process. 2. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product package or shipping carton. 3. Contact Baxter Healthcare Center for Service to arrange for return and credit.Center for Service can be reached at 888-229-0001, Monday through Friday, between the hours of 7:00 AM and 6:00 PM Central Time. Please have your ship-to account number ready when calling. 4. Please do not return the Baxter customer reply form to Baxter. Reply forms should be returned to your supplier. For clinical questions, contact Baxter's Renal Clinical Helpline at 888-736-2543, option 2, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time. For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.
Quantity in commerce: 4,391,520 units
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.
Product codes and lots: Lot Numbers: GD896845, Exp. 10/2015; GD897371, Exp. 01/2016; GD896936, Exp. 10/2015; GD897124, Exp. 11/2015; GD897165, Exp. 12/2015; GD897157, Exp. 12/2015; GD896944, Exp. 11/2015; GD896837, Exp. 10/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1269-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1269-2015	Class II	Completed	Voluntary: Firm initiated	2015-03-25	2015-03-13

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)