FDAFDA · Food and drugs·Recall number Z-0562-2015
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
Published December 17, 2014 · Recall initiated: October 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfm Medical Inc
- Distributor
- Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
- Lot
- Lot No. 1307-065, 1301-009
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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