34 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740
FDA Recall
Terminated
·Depuy Mitek, a Johnson & Johnson Co.·Product code MAI·October 27, 2005
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
FDA Enforcement
Class II
·Terminated·Covidien LP·June 27, 2012
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
Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD·Product code LOJ·March 4, 2003
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
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
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
FDA Recall
Terminated
·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code LOJ·May 9, 2016
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
Access Immunoassay Systems Assay Protocol: Dil-AFP.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code LOJ·July 18, 2005
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
Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
FDA Recall
Terminated
·Abbott Laboratories·Product code LOJ·February 20, 2009