Z-1909-2019Class II

REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for...

Name: Z-1909-2019 REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for...
Creator: Baxter Healthcare Corporation
Published: 2019-05-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2019-05-31 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by... on 2019-05-31. FDA classified it as Class II and gives the reason as "There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment". 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-1909-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-31
Posted: 2019-07-01
Terminated: 2020-10-05
Recalling firm: Baxter Healthcare Corporation
Product: REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Baxter, sent an " Urgent Product Recall" letter on 05/31/2019. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Locate and remove all affected product lots from your facility. The product code and lot number can be found on the individual product or 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 confirmyour receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. 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. 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 Central Time, Monday through Friday. .
Quantity in commerce: 65403 units
Distribution: US Nationwide Distribution and Internationally to: Canada and Bermuda.
Product codes and lots: UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1909-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1908-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-01
Z-1909-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-01

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)