Angiodynamics Inc. (Navilyst Medical Inc.) Recalls

Hazard: Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

Hazard: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Hazard: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.

Hazard: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Hazard: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Hazard: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Hazard: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Hazard: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Hazard: The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.

Hazard: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Hazard: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Hazard: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Hazard: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Hazard: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure

Hazard: specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.

Hazard: Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.

Hazard: BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Hazard: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).