Sage Products Inc
FDA Regulatory Profile
Sage Products Inc appears in FDA public data with 71 recalls — including 1 Class I (most serious) —, 31 510(k) clearances, 9 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-0356-2024, Class II) was initiated on October 23, 2023. Its most recent 510(k) clearance was granted on April 30, 1998.
Summary
- Total Recalls
- 71 (1 Class I)
- 510(k) Clearances
- 31
- Inspections
- 9
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0356-2024 | Class II | stryker Sage PrimaFit External Urine Management System for the Female Anatomy | October 23, 2023 |
| Z-2139-2019 | Class II | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care S | December 5, 2018 |
| D-0388-2018 | Class II | Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2, Contains | August 22, 2017 |
| D-0358-2018 | Class II | Toothette Oral Care Short Term Oral Swab System with Perox-A- Mint solution. Contains 20 Toothette P | August 22, 2017 |
| D-0396-2018 | Class II | Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Conn | August 22, 2017 |
| D-0380-2018 | Class II | Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction | August 22, 2017 |
| D-0381-2018 | Class II | Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages of 2 Suction | August 22, 2017 |
| D-0369-2018 | Class II | Toothette Oral Care Single Use System with Antiseptic Oral Rinse and Mouth Moisturizer. Contains 2 T | August 22, 2017 |
| D-0362-2018 | Class II | Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g tube of Mout | August 22, 2017 |
| D-0411-2018 | Class II | Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three 2-packs of | August 22, 2017 |
| D-0378-2018 | Class II | Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untreated Suction Toothbrush | August 22, 2017 |
| D-0373-2018 | Class II | Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction T | August 22, 2017 |
| D-0375-2018 | Class II | Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction | August 22, 2017 |
| D-0379-2018 | Class II | Toothette Oral Care Suction Swabs with Perox-A-Mint solution and Mouth Moisturizer, Contains 2 Sucti | August 22, 2017 |
| D-0361-2018 | Class II | Toothette Oral Care Short Term Oral Care System with Perox-A-Mint solution, Contains 1.5 fl oz/44 ml | August 22, 2017 |
| D-0400-2018 | Class II | Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Co | August 22, 2017 |
| D-0405-2018 | Class II | Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate | August 22, 2017 |
| D-0389-2018 | Class II | Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-C | August 22, 2017 |
| D-0366-2018 | Class II | Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ml. Sage Products, Inc. | August 22, 2017 |
| D-0404-2018 | Class II | Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate | August 22, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC | April 30, 1998 |
| K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS | February 24, 1998 |
| K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER | October 29, 1997 |
| K972279 | SHARPS SHUTTLE | August 29, 1997 |
| K970135 | NITRILE GLOVES | August 25, 1997 |
| K972302 | POCKET COUNT OR SAFETCOUNT | July 25, 1997 |
| K964168 | PROCEDURE SPECIFIC KITS | March 3, 1997 |
| K963986 | STP SYSTEM PVA WITH ZINC | November 8, 1996 |
| K964026 | STP SYSTEM - SAF | November 7, 1996 |
| K964027 | STP SYSTEM-PVA WITH MERCURY | November 1, 1996 |
| K962168 | MUCUS SPECIMEN TRAP | July 22, 1996 |
| K943660 | PHLEBOTOMY SHARPS DISPOSAL CONTAINERS | March 22, 1995 |
| K943659 | ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS | March 22, 1995 |
| K943658 | CHEMOTHERAPY WASTE DISPOSAL CONTAINERS | March 22, 1995 |
| K941991 | IN-ROOM AND SHARPSTAR | August 29, 1994 |
| K933370 | STOOL TRANSPORT/PROCESSOR | February 17, 1994 |
| K901806 | SUCTION ORA-SWAB(R) BRUSH KIT | August 15, 1990 |
| K894064 | STERILE HAND COVER | August 11, 1989 |
| K874888 | ISOLATION GOWN | December 30, 1987 |
| K873569 | BLOOD NEEDLE HOLDER | November 3, 1987 |