Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment

FDA device recall Z-1644-2014 · posted 2014-05-21 · Terminated

Recall details

Recalling firm

Gambro Renal Products, Incorporated

Reason for recall

The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.

Action taken

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 to Customer Support at 1-800-651-2623.

Root cause

Storage

Status

Terminated

Product code

KDI

Quantity affected

2,461,824 units total

Distribution

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

Date initiated

2014-04-16

Date posted

2014-05-21

Date terminated

2015-12-08

Location

Lakewood, CO

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