FDA Device recall Z-1908-2019
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute ren…
- FDA Device
- Class II
- terminated
- Published 2019-07-10
On 2019-07-10 the FDA classified a Class II recall of REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute ren… by Baxter Healthcare, citing there is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1908-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-31 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason
There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
Identifiers
| code_info | UDI 07332414123055 Lot Numbers: C419105401 C419105501 C419105601 C419105701 C419105801 C419105901 C419106001 C…UDI 07332414123055 Lot Numbers: C419105401 C419105501 C419105601 C419105701 C419105801 C419105901 C419106001 C419106101 C419106201 C419106301 C419106401 C419106501 C419106601 C419106701 C419106801 C419106901 C419107001 C419107101 C419107201 C419107301 C419107401 C419107501 C419107601 C419107701 C419107801 C419107901 C419108001 C419108101 C419108201 C419108301 C419108401 C419108501 C419108601 C419108701 C419108801 C419108901 C419109001 C419109101 C419109201 C419109301 C419109401 C419109501 C419109601 C419109801 C419110001 C419110101 C419110201 C419110301 C419110401 C419110501 C419110601 C419110701 C419110801 C419111001 C419111101 C419111301 C419111501 C419111601 C419111701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1908-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.