Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 13 of 63
Integrity Implants Inc.
Class II Terminated
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and...
Reason: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Z-0418-2023 December 14, 2022 Palm Beach Gardens, FL
Integrity Implants Inc.
Class II Terminated
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixati...
Reason: Potential for intraoperative screw head separation at weld location.
Z-0421-2023 December 14, 2022 Palm Beach Gardens, FL
Southmedic, Inc.
Class II Ongoing
Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO
Reason: Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold ...
Z-0279-2023 November 30, 2022 Barrie, N/A
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0213-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0212-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0211-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0216-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0206-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0209-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0217-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0204-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0207-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0218-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0203-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0210-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0214-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0208-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0215-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0205-2023 November 23, 2022 Vernon Hills, IL
Carefusion 2200 Inc
Class II Ongoing
CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Z-0219-2023 November 23, 2022 Vernon Hills, IL
MEDLINE INDUSTRIES, LP - Northfield
Class II Terminated
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Reason: One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
Z-0106-2023 October 26, 2022 Northfield, IL
Mckesson Medical-Surgical Inc. Corporate Office
Class III Ongoing
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilizat...
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1792-2022 October 5, 2022 Richmond, VA
Mckesson Medical-Surgical Inc. Corporate Office
Class III Ongoing
SPS MEDICAL SUPPLY Crosstex International Sterilization Roll Sani-Roll Ethylene Oxide (EO) Gas / Steam 3 Inch X 100 Foot Transparent / Blue Self Seal Paper / Film Model Number: SCT3.
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1791-2022 October 5, 2022 Richmond, VA
Mckesson Medical-Surgical Inc. Corporate Office
Class III Ongoing
a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Ind...
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1790-2022 October 5, 2022 Richmond, VA
Mckesson Medical-Surgical Inc. Corporate Office
Class III Ongoing
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3...
Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0...
Z-1793-2022 October 5, 2022 Richmond, VA