Z-1409-2020Class II

Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Name: Z-1409-2020 Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Creator: Baxter Healthcare Corporation
Published: 2019-11-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2019-11-15 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L on 2019-11-15. FDA classified it as Class II and gives the reason as "There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1409-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-15
Posted: 2020-02-28
Terminated: 2020-11-20
Recalling firm: Baxter Healthcare Corporation
Product: Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter on 11/15/2019. The letter requests the following actions be taken: "1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected], even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from a distributor, contact your distributor for return and credit. Please note that the Baxter customer reply form is not applicable in this situation. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the reply form. For further information and support: For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Cent
Quantity in commerce: 101976 devices
Distribution: Nationwide
Product codes and lots: UDI 07332414123055, Lot Numbers: C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, C419126401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1409-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1409-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-02-28

Product code KDI

K130039Class IIRevaclear 300 Dialyzer, Revaclear 400 DialyzerGambro Renal Products, Inc. / cleared 2013-05-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)