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

Micro Introducer Kit, 5F Micro Introducer Kit recalled by Pfm Medical

Pfm Medical is recalling Micro Introducer Kit, 5F Micro Introducer 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. 1302-014

Quantity recalled100 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-0563-2015
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

Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, and power injection of contrast media.

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

Is Micro Introducer Kit, 5F Micro Introducer Kit recalled?

Yes. Pfm Medical recalled Micro Introducer Kit, 5F Micro Introducer Kit on 20 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0563-2015.

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. 1302-014

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

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