Reported Dec 17, 2014 · Terminated
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage…
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 2000 ml Drainage BagRef No. 622280
- Product UsageThe ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only
- Lot codes and dates
- Lot No. 1210-028
- Amount recalled
- 370 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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