Merit Medical Systems Recalls

Hazard: 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 difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.

Hazard: There is a potential that a package sheath contains an incorrect dilator.

Hazard: There is a potential that 7F sheaths are packaged as 10F sheaths.

Hazard: There is a potential that 7F sheaths are packaged as 10F sheaths.

Hazard: Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

Hazard: 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 unintended anatomy puncture may occur, which is likely to require medical intervention.

Hazard: 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 unintended anatomy puncture may occur, which is likely to require medical intervention.

Hazard: 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 may lead to an infection requiring medical treatment.

Hazard: 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 may lead to an infection requiring medical treatment.

Hazard: 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 may lead to an infection requiring medical treatment.

Hazard: 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 treatment.

Hazard: 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 treatment.

Hazard: 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 treatment.

Hazard: 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) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

Hazard: 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) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.

Hazard: labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

Hazard: During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.

Hazard: A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

Hazard: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Hazard: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

Hazard: Mix-up between adult and pediatrics PD catheter.

Hazard: Supplier manufacturing defect with the syringe plunger tip.

Hazard: 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.

Hazard: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

Hazard: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.

Hazard: Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

Hazard: Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.

Hazard: Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation valve.

Hazard: Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use.

Hazard: Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.