Dressing, Compression
General Hospital · 21 CFR 880.5075
Recent MDR events
70 adverse event reports on file
- BNDG,TUBLR,MEDIGRIP SZ G 4-3/4W,LFMay 13, 2025InjuryMedline Industries, Lp1417592-2025-00225
- SPANDAGRIP TUBULAR ELASTIC SUPPORT BANDAGESJul 10, 2024InjuryMarketlab Incorporated19709587
- MEDI-TECHJun 27, 2024InjuryMarketlab, Inc3003102481-2024-00024
- BD VECA-C¿ DRESSING PADAug 5, 2022MalfunctionBecton Dickinson9611536-2022-00001
- SURGIGRIP LATEX-FREE SIZE F - 4" X 10 METERSJun 11, 2021InjuryDerma Sciences, Inc.9680091-2021-00008
- PROFORE LITE SYSTEM KIT CASE 8Sep 28, 2020MalfunctionSmith & Nephew Medical Ltd.8043484-2020-02987
- PROFORE LITE SYSTEM KIT CASE 8Feb 23, 2020InjurySmith & Nephew Medical Ltd.8043484-2020-00128
- UNKNOWN PROFOREJan 11, 2020InjurySmith & Nephew Medical Ltd.8043484-2020-00023
- VASCULAR BAND RADIAL COMPRESSIONSep 28, 2018MalfunctionVascular Solutions LlcMW5080207
- TUBIGRIPJan 25, 2017MalfunctionMolnlycke Healthcare, Us Llc6275521
Event type breakdown
Recalls
5 recall events for this product code
- International Medsurg Connection, Inc.TerminatedSep 29, 2006
Allegiance Esmark 4' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undam
The bandages labeled as sterile had not been sterilized prior to distribution.
Z-1527-06 · View FDA record ↗ - International Medsurg Connection, Inc.TerminatedSep 29, 2006
Allegiance Esmark 4' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undam
The bandages labeled as sterile had not been sterilized prior to distribution.
Z-1528-06 · View FDA record ↗ - International Medsurg Connection, Inc.TerminatedSep 29, 2006
Allegiance Esmark 6' x 108' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undam
The bandages labeled as sterile had not been sterilized prior to distribution.
Z-1529-06 · View FDA record ↗ - International Medsurg Connection, Inc.TerminatedSep 29, 2006
Allegiance Esmark 6' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undam
The bandages labeled as sterile had not been sterilized prior to distribution.
Z-1530-06 · View FDA record ↗ - Amd RitmedTerminatedUnknown
IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile banda
Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus.
Z-1251-2016 · View FDA record ↗
Registered firms
239 firms currently registered for this product code
Aid United International Co., Limited
SHANGHAI, CN
Teleflex Medical Llc
Morrisville, NC, US
Garware Fulflex Usa Inc. (previously Avcor Health Care Products, Inc.)
Fort Worth, TX, US
Planet Holdings Limited
Hong Kong, HK
Ready Set Import
Beverly Hills, CA, US
Worldwide Supplies Limited
Hong Kong, HK
Mantality Llc
Santa Ana, CA, US
Zhejiang Longterm Medical Technology Co., Ltd
Huzhou Zhejiang, CN
Harvest Spf Textile(beijing)co.,ltd
Beijing, CN
Sterigenics U.s., Llc
Charlotte, NC, US
American Breast Care Lp
Marietta, GA, US
Ambra Le Roy, Llc
CHARLOTTE, NC, US
Ufeelgood Llc
Boca Raton, FL, US
Vascular Solutions Llc
Maple Grove, MN, US
Acme United Corp.
Rocky Mount, NC, US
Medi Bayreuth
BAYREUTH, BAVARIA, DE
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Merit Medical Uk Limited
Earley Reading, GB
Zhangjiagang Municipal Cnnc Huakang Radiation Co.,ltd.
Zhangjiagang Jiangsu, CN
Suzhou Konlida Medical Supplies Co., Ltd.
Suzhou City Jiangsu, CN
Isomedix Operations, Inc.
Temecula, CA, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Guangdong Tidakang Medical Technology Co., Ltd
ZhongShan City Guangdong, CN
Focus Health Group
Knoxville, TN, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
510(k) clearances
2 clearances for this product code