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Z-0370-2017 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0370-2017 was initiated by Baxter Healthcare Corp. on Oct 12, 2016 and is designated Class II. Reason for recall: Potential presence of particulate matter on the blood side of the dialyzer The recall status is terminated (terminated Aug 19, 2017). Affected quantity: 22,656 units.

Recall Details

Product Type: Devices
Report Date: Nov 16, 2016
Initiation Date: Oct 12, 2016
Termination Date: Aug 19, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22,656 units

Product Description

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.

Reason for Recall

Potential presence of particulate matter on the blood side of the dialyzer

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.

Code Information

C416201601

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