Class I - Dangerous
During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Boston Scientific
Class I - Dangerous
The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.
Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft.
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Class I - Dangerous
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
MEDICAMAT S.A.
Class I - Dangerous
Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER.
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
Medefil Incorporated
Class I - Dangerous
The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).