Z-1909-2019 Class II Terminated
FDA device recall Z-1909-2019 was initiated by Baxter Healthcare Corporation on May 31, 2019 and is designated Class II. Reason for recall: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment. The recall status is terminated (terminated Oct 5, 2020). Affected quantity: 65403 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 10, 2019
- Initiation Date
- May 31, 2019
- Termination Date
- Oct 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65403 units
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.
Distribution pattern
US Nationwide Distribution and Internationally to: Canada and Bermuda.
Code information
UDI 07332414124076 Lot Numbers: C419205101 C419205201 C419205301
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1909-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026