Recall Z-0561-2015— Pfm Medical Inc
Class II · Terminated
Class II FDA medical device recall by Pfm Medical Inc, initiated 2014-10-20, terminated 2015-04-23. It names one FDA 510(k) clearance: K093307. 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.. Reason: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin..
- Recalling firm
- Pfm Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-20
- Terminated
- 2015-04-23
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.