1,565 results found for sterilization
Page 14 of 63
Steris Corporation Hopkins Facility
Class IIITerminated
Verify SixCess Challenge Pack. Used to confirm that critical parameters of steam sterilization have been reached within a challenging test pack design.
Reason: Product contains incorrect chemical indicators in packaging.
Z-1736-2022September 21, 2022Mentor, OH
American Contract Systems, Inc.
Class IIOngoing
Various ob/gyn packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1701-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various hysterectomy, vaginal packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1702-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various Pacemaker Packs, Cardio Thoracic Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1691-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various ENT Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1693-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various PICC Line, Central Line Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1692-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various C-section packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1703-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
D&C pack
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1704-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various convenience packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1699-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various convenience packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1698-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various Port Insertion Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1696-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various Angiography/Cath Lab packs/trays
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1690-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various Cysto Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1695-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various neurology packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1700-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Breast Abdominoplasty Pack
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1697-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various Angiography packs/trays
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1689-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various Laparoscopy Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1694-2022September 14, 2022Kansas City, MO
American Contract Systems, Inc.
Class IIOngoing
Various eye packs, cataract packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1705-2022September 14, 2022Kansas City, MO
Wright Medical Technology, Inc.
Class IIOngoing
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Reason: The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detai...
Reason: Due to a potential failed sterilization process.
Z-1270-2022June 22, 2022San Diego, CA
Tornier, Inc
Class IIOngoing
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Reason: The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Z-1216-2022June 8, 2022Bloomington, MN
Olympus Corporation of the Americas
Class IIOngoing
BF-MP60: OES Bronchofiberscope
Reason: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfectio...
Z-1046-2022May 18, 2022Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
BF-3C160: EVIS EXERA Bronchovideoscope
Reason: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfectio...
Z-1047-2022May 18, 2022Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
BF-1TQ180: EVIS EXERA II Bronchovideoscope
Reason: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfectio...
Z-1049-2022May 18, 2022Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Reason: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfectio...