ASEPT Pleural Drainage System — Class II medical device recall Z-0561-2015
Terminated recall by Pfm Medical Inc, reported 2014-12-17, distributed nationwide. PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial
| Recall number | Z-0561-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfm Medical Inc, Carlsbad, CA, United States |
| Recall initiated | 2014-10-20 |
| Classified | 2014-12-09 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, MY |
| Quantity | 120 units |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 1210-015, 1302-031, 1307-024 |
| Model numbers | M7001, P09080001 |
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 for recall
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0561-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.