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Baxter Healthcare Corp. Recall: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STER

Baxter Healthcare Corp. Recall: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STER is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Baxter Healthcare Corp.; Product: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear M

Recalling firmBaxter Healthcare Corp.
ProductGAMBRO 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 recallPotential presence of particulate matter on the blood side of the dialyzer
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide Distribution - US Nationwide and the countries of Canada and Mexico.
Recall initiated20161012
Recall numberZ-0370-2017
Categorydevice
StateIL
CountryUnited States

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