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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a potential sterile barrier breach could lead to infection, but no injuries or illnesses have been reported yet, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 88,040 units (8,804 boxes) of Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO. These single-use surgical gowns are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids. The affected units were distributed nationwide in the United States.
The recall is based on accelerated aging tests for the product packaging, which indicated a potential for a breach in the sterile barrier of the header bag and potentially the blue sterilization wrap. This potential breach was identified within the second and third year of the product's shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing the product.
Healthcare facilities and consumers should check their inventory for the specific lot codes listed in the recall notice. If the product is found, it should be removed from use and returned to Stryker Instruments for credit or replacement.
The recalled product
- 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Gowns
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1005097
- 1008188
- 1011281
- 1103194
- 1106465
- 1107519
- 1005105
- 1008192
- 1011296
- 1103201
- 1107501
- 1109763
- 1005111
- 1009198
- 1012303
- 1103223
- 1107550
- 1109777
- 1005118
- 1009213
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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