Organ Recovery Systems, Inc.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1437-2020 | Class II | LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The cir | January 30, 2020 |
| Z-1111-2017 | Class II | SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce | December 14, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L | March 11, 2010 |
| K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) | July 31, 2003 |
| K022391 | MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION | October 21, 2002 |
| K013575 | KPS-I, THE KIDNEY PERFUSION SOLUTION | January 25, 2002 |