FDA Device Intelligence
HomeCardinal Health, Inc. › Salem Sump

Salem Sump

Cardinal Health, Inc. · Model 8888265108E · UDI-DI 10884521740693

FEGPIF Prescription
10
510(k) clearances
345
Adverse events (5 deaths)
14
Recalls
29
Facilities

Description

SILICONE SALEM SUMP ENFIT 10FR 36IN

Recalls

DateFirmReason
2025-09-18Cardinal Health 200, LLCFirm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
2025-09-18Cardinal Health 200, LLCFirm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
2024-07-24Cardinal Health 200, LLCThe firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ
2023-12-20C.R. Bard IncBD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occ

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 docs
Data 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.