Reported Dec 17, 2014 · Terminated
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical…
Pfm Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pfm Medical Inc · 1815 Aston Ave Ste 106 · Carlsbad, CA · 92008-7340
Is this the product you have?
- ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001
- M7001 Product UsageThe 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
- Lot codes and dates
Lot No. 1307-0241302-0311210-015
- Amount recalled
- 120 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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