Pfm Medical Inc
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 20
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0560-2015 | Class II | Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutane | October 20, 2014 |
| Z-0566-2015 | Class II | Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term per | October 20, 2014 |
| Z-0562-2015 | Class II | ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an acce | October 20, 2014 |
| Z-0563-2015 | Class II | Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are | October 20, 2014 |
| Z-0568-2015 | Class II | ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used f | October 20, 2014 |
| Z-0564-2015 | Class II | 6F x 60 cm Dual Lumen CT PICC, Ref No. PFM2CT6D Product Usage:The PFM CT PICC catheter is indicat | October 20, 2014 |
| Z-0561-2015 | Class II | ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Us | October 20, 2014 |
| Z-0567-2015 | Class II | Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Cath | October 20, 2014 |
| Z-0565-2015 | Class II | ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Periton | October 20, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242763 | JetCan® Pro Safety Huber Needle | May 2, 2025 |
| K241278 | ASEPT® Glide Peritoneal Drainage System | January 14, 2025 |
| K221779 | ASEPT Peritoneal Drainage System | May 2, 2023 |
| K213666 | NuCath Wedge Pressure Catheter | October 6, 2022 |
| K201137 | Asept Surgical Face Mask | August 19, 2020 |
| K192802 | primeMidline Catheters | October 28, 2019 |
| K173114 | primeMidline Catheters | March 7, 2018 |
| K140137 | SAFETY BIOPSY NEEDLE SYSTEM | March 25, 2014 |
| K122402 | LPP (LOW PROFILE PORT) | July 16, 2013 |
| K113354 | VETA PERITONEAL DIALYSIS CATHETER | March 13, 2012 |
| K110914 | TRIPLE LUMEN PFM PICC | September 21, 2011 |
| K093796 | ASEPT PERITONEAL DRAINAGE SYSTEM | February 26, 2010 |
| K093307 | ASEPT PLEURAL DRAINAGE SYSTEM | November 6, 2009 |
| K083873 | PICC (CT RATED AND NON-RATED) | March 19, 2009 |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | March 7, 2008 |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | December 12, 2007 |
| K072391 | PFM PICC | November 19, 2007 |
| K071993 | T-PORT HP INFUSION PORT | October 17, 2007 |
| K071846 | MODIFICATION TO EZ HUBER SAFETY INFUSION SET | August 30, 2007 |
| K040533 | EZ HUBER SAFETY INFUSION SET | September 17, 2004 |