Class II — Pfm Medical Inc
| Recalling firm | PFM Medical |
|---|---|
| Registered facility | pfm medical cpp SA (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| 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. |
| Quantity | 120 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia. |
| Initiated | 2014-10-20 |
| Classified | 2014-12-09 |
| Terminated | 2015-04-23 |
| Recall number | Z-0561-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Pfm Medical Inc (Z-0561-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69666/
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