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.
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 is classified as FDA Class II. The hazard involves a potential breach in the sterile barrier, which poses a risk of infection (risk-of-harm product) but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 7,960 units (796 boxes) of Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO. These single-use surgical gowns are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids.
The recall was initiated following an accelerated aging test for the product packaging. The test, which used high heat to accelerate the aging of the packaging, indicated a 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. Stryker is conducting additional testing and assessing the product.
The affected products were distributed nationwide in the USA. The specific lot codes involved are 1006129, 1103201, 1009197, 1105391, 1009198, 1107548, 1012302, 1109788, and 1102127. Healthcare facilities should check their inventory for these specific lot codes and stop using the affected products.
The recalled product
- 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 tr
- 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 (9)
- 1006129
- 1103201
- 1009197
- 1105391
- 1009198
- 1107548
- 1012302
- 1109788
- and 1102127
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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