REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Reported: July 10, 2019 Initiated: May 31, 2019 #Z-1909-2019
Product Description
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason for Recall
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 65403 units
- Distribution
- US Nationwide Distribution and Internationally to: Canada and Bermuda.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.. Recalled by Baxter Healthcare Corporation. Units affected: 65403 units.
Why was this product recalled? ▼
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1909-2019.
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