Recall Z-1644-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
| Date | May 21, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. |
| Root cause | Storage |
| Action | The recall was initiated by an Urgent: Medical Device Recall letter delivered by UPS Overnight Delivery on April 16, 2014. The letter identified the affected product and reason for the recall. The firm is asking customers to remove and quarantine any remaining affected product from their inventory for collection and replacement. Customers are to also complete and return the Customer Reply Form to the Gambro Regulatory Affairs Department. Customers with affected product are to contact Gambro Customer Support or their Gambro representative to return the product. Questions should be directed |
| Quantity | 2,461,824 units total |
| Distribution | Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE Gambro Renal Products, Apr 24, 2006 |