FDAFDA · Food and drugs·Recall number Z-0560-2015
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
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. 1401-040
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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