pfm medical cpp SA
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (2)
Devices registered here (1)
- Port & Catheter, Implanted, Subcutaneous, IntravascularProduct code LJT (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5965
Recalls & enforcement
- Class IIOngoing2026-04-21A 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 IITerminated2014-10-20PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
FDA inspections (2)
- VAI2023-01-12Voluntary Action Indicated · Compliance: Devices · citations posted
- NAI2016-11-30No 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.
Related
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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