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.
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- October 12, 2016
- Posted
- November 8, 2016
- Terminated
- August 19, 2017
- Recall Number
- Z-0370-2017
- Quantity
- 22,656 units
- Firm Location
- Deerfield, IL
Reason for Recall
Potential presence of particulate matter on the blood side of the dialyzer
Distribution
Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Lot / Code Info
C416201601
Root Cause
Process control
Action Taken
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.
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