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Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
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Stryker Instruments0400-750-000 T4 Toga, Pullover, Regular Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
View Details
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
View Details
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material. Class II

Reason: Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Stryker Instruments Div. of Stryker Corporation 20130523 Terminated
Distributed: USA Nationwide Distribution
View Details
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