Applicator, Vaginal
Obstetrics/Gynecology · 21 CFR 884.4520
Recent MDR events
16 adverse event reports on file
- FRIDA FERTILITY AT-HOME INSEMINATION SET - 3CTMay 18, 2023InjuryFrida Fertility / Fridababy LlcMW5117725
- MXAPP TRIMO SAN JEL-JECTORApr 12, 2021MalfunctionCoopersurgical, Inc.1216677-2021-00065
- ESTRADIOLJun 16, 2020MalfunctionUnkMW5095042
- JEL-JECTOR,APPLICATORSep 24, 2019MalfunctionCoopersurgical, Inc.1216677-2019-00263
- GM11011160 UNIVERSAL STUMP APPLICATOR SETMay 17, 2019InjuryVarian Medical Systems Haan Gmbh9612638-2019-00001
- MX5030 TRIMO SANApr 12, 2019MalfunctionCoopersurgical, Inc.1216677-2019-00055
- TRIMO SANFeb 28, 2019InjuryCoopersurgical, Inc.1216677-2019-00105
- MXAPP TRIMO SAN JEL-JECTOROct 15, 2018MalfunctionCoopersurgical, Inc.1216677-2018-00052
- TRIMO SANMay 22, 2017MalfunctionCoopersurgical, Inc.1216677-2017-00037
- TRIMO SANJan 24, 2017MalfunctionCoopersurgical, Inc.1216677-2017-00002
Event type breakdown
Recalls
2 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 6, 2024
Medline Convenience kits labeled as:
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-3043-2024 · View FDA record ↗ - Carefusion 2200 IncTerminatedMar 14, 2012
Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iod
The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution, which may represent a patient safety hazard.
Z-1209-2012 · View FDA record ↗
Registered firms
61 firms currently registered for this product code
Xinhua Surgical Instrument Co. Ltd.
ZIBO Shandong, CN
Innovative Medical Manufacturing Co.
Zhunan Township, Miaoli County, TW
Plus Ev Holdings Inc
North Kansas City, MO, US
Live Well Brands, Inc.
Ventura, CA, US
Mai/genesis
ELMWOOD, WI, US
Hti Plastics, A Division Of Pce Inc.
Lincoln, NE, US
Hospital Equipment Mfg. Co.
NOIDA Uttar Pradesh, IN
Cordica Medical, Inc. (formally Team Technologies, Inc.)
MORRISTOWN, TN, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Apothecary Products, Llc.
BURNSVILLE, MN, US
Sterigenics U.s., Llc
Ontario, CA, US
Seed Health Inc
New York, NY, US
Guang Xi Fulaiming Biopharmaceutics Co., Ltd.
Nanning Guangxi, CN
Aimi Health Technology (guangdong) Co., Ltd.
Dongguan City Guangdong, CN
Tekno Medical Optik-chirurgie Gmbh
TUTTLINGEN-Nendingen Baden-Wurttemberg, DE
Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd
Foshan City Guangdong, CN
Src Medical, Inc.
Hanover, MA, US
Shun Ho (bangladesh) Manufactory Limited
Cumilla Zilla Chittagong (Division), BD
Inge Spa
Garbagnate Milanese Milano, IT
Mattes Instrumente Gmbh
Tuttlingen-Nendingen Baden-Wurttemberg, DE
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Sonoco Plastics B.v.
Berkel en Rodenrijs Zuid-Holland, NL
Pixie Cup Llc
Walnut Shade, MO, US
Reia, Llc
Portland, ME, US
Pelvana Health, Llc
Fort Worth, TX, US
510(k) clearances
1 clearances for this product code