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.
FDA Recall Z-0370-2017 · Posted 2016-11-08
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeKDL
Date Initiated2016-10-12
Date Terminated2017-08-19
Product Quantity22,656 units
Reason for Recall
Potential presence of particulate matter on the blood side of the dialyzer
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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