Gambro Renal Products Inc Recall: Polyflux Revaclear Max Dialyzer, Model Number 110634. Th
Gambro Renal Products Inc Recall: Polyflux Revaclear Max Dialyzer, Model Number 110634. Th is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Gambro Renal Products Inc; Product: Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialy
| Recalling firm | Gambro Renal Products Inc |
|---|---|
| Product | Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis. |
| Reason for recall | Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC. |
| Recall initiated | 20141105 |
| Recall number | Z-0490-2015 |
| Category | device |
| State | AL |
| Country | United States |
$29/mo
Try RecallGuard →