Z-0370-2017Class II

GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634

Name: Z-0370-2017 GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Creator: Baxter Healthcare Corp.
Published: 2016-10-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2016-10-12 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for... on 2016-10-12. FDA classified it as Class II and gives the reason as "Potential presence of particulate matter on the blood side of the 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-0370-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Posted: 2016-11-08
Terminated: 2017-08-19
Recalling firm: Baxter Healthcare Corporation
Product: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Product code: KDL Set, Perfusion, Kidney, Disposable
Reason for recall: Potential presence of particulate matter on the blood side of the dialyzer
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter sent an Urgent Product Recall letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: I. Locate and remove all affected product lots from their facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. For questions contact Baxter Product Surveillance at 800-437-5176.
Quantity in commerce: 22,656 units
Distribution: Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Product codes and lots: C416201601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0370-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0370-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-08

Product code KDL

K060195Class IIGambro Polyflux Hd-C4 Capillary Dialyzer/filter for Single UseGambro Renal Products / cleared 2006-04-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)