Z-0563-2015Class II

Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005

Name: Z-0563-2015 Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005
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 Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic... 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-0563-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-20
Posted: 2014-12-12
Terminated: 2015-04-23
Recalling firm: PFM Medical GmbH
Product: 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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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: 100 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. 1302-014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0563-2015
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 LJS

K083873Class IIPicc (CT Rated and Non-Rated)Pfm Medical, Inc. / cleared 2009-03-19

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)