Facility
PFM Medical, Inc
2 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3013666218 |
|---|---|
| Establishment type | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device for Another Party (Contract Manufacturer); Repack or Relabel Medical Device; Manufacture Medical Device |
| Location | 1916 Palomar Oaks Way Carlsbad, CA, US 92008 |
| Registration status | Active · expires 2026 |
| Parent company | PFM MEDICAL, INC (owner-operator 9052164) |
| Brand names | Veta Peritoneal Dialysis Catheter |
Devices registered here (1)
- Catheter, Peritoneal, Long-Term IndwellingProduct code FJS · Class II · Gastroenterology, Urology · 21 CFR 876.5630
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 inflam
- Class IITerminated2014-10-20PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
Watch PFM Medical, Inc
We'll email you when a new FDA recall or enforcement record is published for a facility you follow. (Inspection & warning-letter coverage is being added.)
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.