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.
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 medical device where a sterile barrier breach could lead to infection, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 34,640 units (3,464 boxes) of Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large sterile, EO single-use products. These products are intended to protect patients and healthcare personnel against contamination and exposure to infectious bodily fluids.
The recall was initiated after an accelerated aging test indicated a potential for a breach in the sterile barrier of 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. The test method used high heat to accelerate the aging of the packaging. Stryker is currently conducting additional testing and assessing the product.
The affected products were distributed nationwide in the USA. Healthcare facilities and consumers should stop using these products and contact Stryker for further instructions.
The recalled product
- 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 th
- 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)
- 1006134
- 1012304
- 1104308
- 1007152
- 1101020
- 1105365
- 1007170
- 1102080
- 1106421
- 1008188
- 1102147
- 1106469
- 1009205
- 1103193
- 1108628
- 1010229
- 1103198
- 1108697
- 1010253
- 1102149
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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