Device product
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The 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.
Z-0561-2015
Product summary
- Firm
- Pfm Medical Inc
- Event
- Event 69666
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0561-2015
Official wording
Reason: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Code information: Lot No. 1307-024, 1302-031, 1210-015
Distribution pattern: Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Derived failure modes
-
Unknown
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.