Sage Products Inc

FDA Regulatory Profile

Summary

Total Recalls
71 (1 Class I)
510(k) Clearances
31
Inspections
9
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0356-2024Class IIstryker Sage PrimaFit External Urine Management System for the Female AnatomyOctober 23, 2023
Z-2139-2019Class IIToothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care SDecember 5, 2018
D-0354-2018Class IIQCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse CAugust 22, 2017
D-0365-2018Class IIToothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Moisturizer. Contains 2 August 22, 2017
D-0364-2018Class IIToothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 Toothette Plus swabs wAugust 22, 2017
D-0371-2018Class IIQ Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction ToothbrAugust 22, 2017
D-0398-2018Class IIQ.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. CoAugust 22, 2017
D-0402-2018Class IIQ.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine GluconateAugust 22, 2017
D-0403-2018Class IIQ.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine GluconateAugust 22, 2017
D-0363-2018Class IIToothette Oral Care Daily Oral Cleansing Kit Petite Size with Antiseptic Oral Rinse. Contains: 10 PeAugust 22, 2017
D-0406-2018Class IIQ Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral RiAugust 22, 2017
D-0377-2018Class IIQ CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 SuctionAugust 22, 2017
D-0349-2018Class IIQ Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 SAugust 22, 2017
D-0391-2018Class IIToothette Oral Care Suction Toothbrush with Perox-A-Mint solution. Contains 1 Suction Toothbrush witAugust 22, 2017
D-0356-2018Class IIOral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush pAugust 22, 2017
D-0383-2018Class IIToothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush wAugust 22, 2017
D-0351-2018Class IIQCare Oral Cleansing and Suctioning System with Corinz. Includes: Two (2) Suction Toothbrush packageAugust 22, 2017
D-0360-2018Class IIToothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, Contains 20 Toothette PlAugust 22, 2017
D-0376-2018Class IIQ CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 SuctionAugust 22, 2017
D-0407-2018Class IIQ Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral RiAugust 22, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICApril 30, 1998
K980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSFebruary 24, 1998
K9739112 GALLON ALTERNATE CARE SHARPS CONTAINEROctober 29, 1997
K972279SHARPS SHUTTLEAugust 29, 1997
K970135NITRILE GLOVESAugust 25, 1997
K972302POCKET COUNT OR SAFETCOUNTJuly 25, 1997
K964168PROCEDURE SPECIFIC KITSMarch 3, 1997
K963986STP SYSTEM PVA WITH ZINCNovember 8, 1996
K964026STP SYSTEM - SAFNovember 7, 1996
K964027STP SYSTEM-PVA WITH MERCURYNovember 1, 1996
K962168MUCUS SPECIMEN TRAPJuly 22, 1996
K943658CHEMOTHERAPY WASTE DISPOSAL CONTAINERSMarch 22, 1995
K943659ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERSMarch 22, 1995
K943660PHLEBOTOMY SHARPS DISPOSAL CONTAINERSMarch 22, 1995
K941991IN-ROOM AND SHARPSTARAugust 29, 1994
K933370STOOL TRANSPORT/PROCESSORFebruary 17, 1994
K901806SUCTION ORA-SWAB(R) BRUSH KITAugust 15, 1990
K894064STERILE HAND COVERAugust 11, 1989
K874888ISOLATION GOWNDecember 30, 1987
K873569BLOOD NEEDLE HOLDERNovember 3, 1987