Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 19 of 63

LivaNova USA Inc

Class II Terminated

VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0...

Reason: Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

Z-1118-2020 February 19, 2020 Houston, TX

Medtronic Xomed, Inc.

Class II Ongoing

Lamicel 10PK 10MM INTL

Reason: Routine sterilization dose does not meet the required Sterility Assurance Level.

Z-0735-2020 January 1, 2020 Jacksonville, FL

Medtronic Xomed, Inc.

Class II Ongoing

Lamicel 20PK 3MM INTL Cervical dilator

Reason: Routine sterilization dose does not meet the required Sterility Assurance Level.

Z-0733-2020 January 1, 2020 Jacksonville, FL

Medtronic Xomed, Inc.

Class II Ongoing

Lamicel 20PK 5MM INTL

Reason: Routine sterilization dose does not meet the required Sterility Assurance Level.

Z-0734-2020 January 1, 2020 Jacksonville, FL

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0653-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0640-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0627-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0621-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0630-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0639-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0622-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0620-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0648-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0619-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0629-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0646-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0637-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0651-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0638-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0628-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0626-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0615-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0624-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0617-2020 December 18, 2019 Plainsboro, NJ

Integra LifeSciences Corp.

Class II Terminated

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Reason: The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual stat...

Z-0650-2020 December 18, 2019 Plainsboro, NJ