FDA (Devices) recall action 65321

Stryker Instruments Div. of Stryker Corporation recalled 16 products on 2013-06-12

The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products: 16
Announced: 2013-06-12
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–16 of 16

ModerateFDA (Devices)··2013-06-12
Stryker T4 Toga Surgical Gowns Recalled for Potential Sterile Barrier Breach
Stryker is recalling 3,000 units of T4 Toga surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states
ModerateFDA (Devices)··2013-06-12
Stryker T4 Pullover Toga Recall Due to Sterile Barrier Concerns
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.
Product
Stryker Instruments 0400-850-100 T5 zipper Toga with 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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-840-000 T4 Toga, Zipper, 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2013-06-12
Stryker T4 Toga Surgical Drapes Recalled for Sterile Barrier Concerns
Stryker is recalling T4 Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T4 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-710-000 T4 Pullover 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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states
ModerateFDA (Devices)··2013-06-12
Stryker Instruments Toga Sterile Barrier Recall
Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Product
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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T4 Zipper Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging during the second and third years of shelf life.
Product
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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T5 Zipper Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T5 Zipper Toga surgical drapes due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states
ModerateFDA (Devices)··2013-06-12
Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.
Product
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2013-06-12
Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.
Product
Stryker Instruments 0400-830-000 T4 Toga, Zipper, 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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Toga pullovers because accelerated aging tests suggest the sterile barrier may fail within the second or third year of shelf life.
Product
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…
Category
Distribution
0 states
HighFDA (Devices)··2013-06-12
Stryker Instruments T4 Toga Zipper Recall for Sterile Barrier Concerns
Stryker is recalling T4 Toga Zipper sterile surgical gowns due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Product
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) 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…
Category
Distribution
0 states
ModerateFDA (Devices)··2013-06-12
Stryker T4 Toga Pullover Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
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…
Category
Distribution
0 states