CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

Asept Pleural Drainage System, Pleural Drainage Catheter Kit recalled

Pfm Medical is recalling Asept Pleural Drainage System, Pleural Drainage Catheter Kit, distributed nationwide in the US. The recall was initiated on 20 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 1307-024, 1302-031, 1210-015

Quantity recalled120 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0561-2015
FDA event ID: 69666
Recalling firm: Pfm Medical, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2014
FDA classified: 9 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

20 Oct 2014	Recall initiated by company
9 Dec 2014	Classified by FDA	+50 days
17 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

Nationwide Louisiana Massachusetts North Carolina Ohio Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

Which lots are affected?

Lot No. 1307-024, 1302-031, 1210-015

Where was it sold?

Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 69666

Reported	Class	Recall	Company	Reason	Where
17 Dec 2014	CLASS II	6F Dual Lumen CT PICC recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Asept Peritoneal Drainage System recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Micro Introducer Kit, 5F Micro Introducer Kit recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Veta Peritoneal Catheter Kit, Curled recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Thoracentesis & Paracentesis Procedure Tray recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Rapid Centesis Catheter recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Asept Drainage Kit recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014	CLASS II	Asept Drainage recalled by Pfm Medical	Pfm Medical	Other	Nationwide

More recalls from Pfm Medical

All 10

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Multi-Snare Set recalled by Pfm Medical	PFM Medical	Other	Nationwide
17 Dec 2014Device	CLASS II	Asept Drainage recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014Device	CLASS II	Asept Drainage Kit recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014Device	CLASS II	Rapid Centesis Catheter recalled by Pfm Medical	Pfm Medical	Other	Nationwide
17 Dec 2014Device	CLASS II	Thoracentesis & Paracentesis Procedure Tray recalled by Pfm Medical	Pfm Medical	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide