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ASEPT Peritoneal Drainage System

PFM MEDICAL INCORPORATED · Model M7008 · UDI-DI 00813623017061

PNG Prescription

510(k) clearances

179

Adverse events (3 deaths)

Recalls

Facilities

Description

ASEPT Peritoneal Drainage System

Recalls

Date	Firm	Reason
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.
2023-04-22	Merit Medical Systems, Inc.	There is a potential that valve assemblies will not open. preventing fluid from draining.

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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.