Entity profile compiled from public source records
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0028-2016 | regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0029-2016 | regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0030-2016 | regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0031-2016 | regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0032-2016 | regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0033-2016 | regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0034-2016 | regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0035-2016 | regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0036-2016 | regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0037-2016 | regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0038-2016 | regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0039-2016 | regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0040-2016 | regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0041-2016 | regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0042-2016 | regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit containing cover light handle soft, Rx. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0043-2016 | regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
| Z-0044-2016 | regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility. | 2015-04-22 | Terminated | View Details |
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.