70 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8%
FDA Recall
Terminated
·Sybron Dental Specialties·Product code JOJ·February 25, 2003
Cidexplus Solution Test Strips
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·March 16, 2005
Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX PLUS Products''
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·September 4, 2003
VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.
FDA Recall
Terminated
·Steris Corporation·Product code JOJ·December 19, 2013
Gluteraldehyde Concentration Indicators ''Browne GA Indicator for CIDEX Products''
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·September 4, 2003
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code JOJ·August 10, 2022
3M Attest Steam Chemical Integrators, REF 1243B
FDA Recall
Open, Classified
·3M Company Health Care Business 3m Center·Product code JOJ·April 6, 2023
Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
FDA Recall
Terminated
·Propper Mfg Co Inc·Product code JOJ·February 7, 2008
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132C (270F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·June 10, 2013
Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·September 4, 2003
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
FDA Recall
Terminated
·Product code JOJ·August 9, 2006
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process.
FDA Recall
Open, Classified
·Young Dental Mfg Co I LLC·Product code JOJ·December 29, 2021
Cidex Plus Test Strips
FDA Recall
Terminated
·Advanced Sterilization Products·Product code JOJ·December 17, 2003
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance.
FDA Recall
Terminated
·Resource Optimization & Innovation LLC·Product code JOJ·June 17, 2020
a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JOJ·May 25, 2022
3M Attest Steam Chemical Integrators, REF 1243A
FDA Recall
Open, Classified
·3M Company Health Care Business 3m Center·Product code JOJ·April 6, 2023
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code JOJ·May 25, 2022
3M Comply EO Chemical Indicators Strips, Catalog #1251 The Comply 1251 Chemical Indicator Strip is a paper strip 1.5cm wide by 20 cm long (0.625 inches wide by 8 inches long) printed with a chemical indicator ink that turns from red to green when exposed to ethylene oxide (EO) sterilization process. It is designed to indicate whether EO has penetrated to the point of placement of the strip, usually the center of the pack. Each strip is perforated at the center if a shorter internal chemical indicator is preferred. An internal chemical indicator should be used inside each pack to be sterilized. 3M Health Care 3M Center Bldg 275-4E-011, St. Paul, MN 55144-1000
FDA Recall
Terminated
·Product code JOJ·March 19, 2008
Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)
FDA Recall
Open, Classified
·Product code JOJ·December 7, 2023
Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.
FDA Recall
Terminated
·Steritec Products Mfc. Co., Inc.·Product code JOJ·July 15, 2009