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.
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 barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 2,980 units (298 boxes) of Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M). These sterile, single-use products 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 was initiated following an accelerated aging test for the product packaging. The test, which used high heat to accelerate aging, indicated a potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap. This potential breach could occur within the second and third year of the product's shelf life. Stryker is currently conducting additional testing and assessing the product.
The recalled product
- 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Drapes
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 (3)
- 1006134
- 1101020
- 1106424
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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