Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 recallZ-0563-2015 · Pfm Medical Inc · initiated Oct 20, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pfm Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0563-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 20, 2014
- Posted by the FDA
- Dec 12, 2014
- Recalling firm
- Pfm Medical Inc
- Quantity
- 100 units
- Product code
- LJS
- FDA submissions
- K083873
- Distribution
- Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.
Product description
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.
Code information (models, lots, serial numbers)
Lot No. 1302-014
Other devices under the same FDA submission
2 devices cleared under K083873 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- primePICC PFM2CT5DLPfm Medical Incorporated · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days5 reports
- PICC Prime PFM2CT5DPfm Medical Incorporated · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 69666).
- Z-0564-2015 · Terminated6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous system for intra…
- Z-0565-2015 · TerminatedASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated f…
- Z-0568-2015 · TerminatedASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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