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U.S. Department of Health and Human Services

Class 2 Device Recall Polyflux(R) Revaclear MAX

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  Class 2 Device Recall Polyflux(R) Revaclear MAX see related information
Date Initiated by Firm October 12, 2016
Date Posted November 08, 2016
Recall Status1 Terminated 3 on August 19, 2017
Recall Number Z-0370-2017
Recall Event ID 75414
510(K)Number K060195  
Product Classification Set, perfusion, kidney, disposable - Product Code KDL
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.
Code Information C416201601
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Baxter Healthcare Center for One
800-422-9837
Manufacturer Reason
for Recall		 Potential presence of particulate matter on the blood side of the dialyzer
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDL and Original Applicant = GAMBRO RENAL PRODUCTS
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