FDA-Device2019-07-10Class II
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Hazard
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Sold states
US Nationwide Distribution and Internationally to: Canada and Bermuda.
Affected count
1249272 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1908-2019More Baxter Healthcare Corporation recalls
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- FDA-Device2026-07-08Hillrom VOLARA System P.CIRCUIT KIT recalled for nebulizer cup leakage risk
- FDA-Device2026-07-08Hillrom Volara P.Circuit 5Kit breathing device recalled for nebulizer cup leakage risk
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