Z-0561-2015Class II

ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001

Name: Z-0561-2015 ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001
Creator: Pfm Medical Inc
Published: 2014-10-20
License: https://open.fda.gov/license/

PFM Medical GmbH / initiated 2014-10-20 / Terminated / root cause: manufacturing process

FDA source

Pfm Medical Inc began a recall of ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a... on 2014-10-20. FDA classified it as Class II and gives the reason as "PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0561-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-20
Posted: 2014-12-12
Terminated: 2015-04-23
Recalling firm: PFM Medical GmbH
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.
Product code: DWM Apparatus, Suction, Patient Care
Reason for recall: PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to [email protected]. Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749.
Quantity in commerce: 120 units
Distribution: Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Product codes and lots: Lot No. 1307-024, 1302-031, 1210-015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0560-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0561-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0562-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0563-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0564-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0565-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0566-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0567-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09
Z-0568-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code DWM

K093307Class IIAsept Pleural Drainage SystemPfm Medical, Inc. / cleared 2009-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)