Merit Medical Systems Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507 recall — FDA Z-1913-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Overview of recall records associated with Merit Medical Systems, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 101, Class I: 5.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
There is a potential that valve assemblies will not open. preventing fluid from draining.
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which…
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which…
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in…
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in…
There is a potential that 7F sheaths are packaged as 10F sheaths.
There is a potential that a package sheath contains an incorrect dilator.
There is a potential that 7F sheaths are packaged as 10F sheaths.
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an…
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an…
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which…
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which…
Angiography/Angioplasty custom kits contain header bags which may not be fully sealed, resulting in a compromised sterile barrier. This could result in exposure to non-sterile devices which…
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in…
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in…
The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in…
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5)…
This page summarizes recall records in which the official source identifies Merit Medical Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.