Home › FENWAL, INC. › NA
NA
FENWAL, INC. · Model 4C4502 · UDI-DI 00811137010431
CAK
Prescription
10
510(k) clearances
1,660
Adverse events (7 deaths)
1
Recalls
14
Facilities
Description
Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GVS TM, Inc | Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.