Reported Dec 17, 2014 · Terminated
Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the…
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?
- Micro Introducer Kit, 5F Micro Introducer Kit, Ref No
- M4005 Product UsageThese introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media
- Lot codes and dates
- Lot No. 1302-014
- Amount recalled
- 100 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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