Facility

pfm medical cpp SA

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008737795
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	ALLEE DU QUARTZ 9 LA CHAUX-DE-FONDS Neuchatel, CH 2300
Registration status	Active · expires 2026
Parent company	PFM Medical (owner-operator 9020573)
Brand names	JetPort Plus Catheter System

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Port & Catheter, Implanted, Subcutaneous, Intravascular
Product code LJT (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5965

Recalls & enforcement

Class IIOngoing2026-04-21
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammatio…
Class IITerminated2014-10-20
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

FDA inspections (2)

VAI2023-01-12
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2016-11-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by PFM Medical

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “pfm medical cpp SA (FEI 3008737795) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008737795-pfm-medical-cpp-sa/

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