FDA Device recall Z-0561-2015
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainag…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainag… by Pfm Medical, citing PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0561-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-20 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pfm Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lot No. 1307-024, 1302-031, 1210-015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0561-2015%22
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