Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ASEPT Pleural Drainage System Recalled by Pfm Medical Inc Due to PFM Medical is recalling catheters and other medical...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pfm Medical Inc directly.
Affected Products
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
Quantity: 120 units
Why Was This Recalled?
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pfm Medical Inc
Pfm Medical Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report