OSCOR ADELANTE BREEZEWAY 8F C90 S79CM D84CM Catalog # AB081046 Is designed to facilitate the recall — FDA Z-0796-2017
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
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Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated…
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results…
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
A limited number of product pouches may not have been sealed during packaging.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for…
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
A limited number of product pouches may not have been sealed during packaging.
A limited number of product pouches may not have been sealed during packaging.
Browse recent months with enough recall history for useful comparison.