Stryker T4 Pullover Toga Recall Due to Layer Separation
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.
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 where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling T4 Pullover Toga, Large sterile personal protection garments. The recall involves 34,570 units distributed in the United States, Ireland, Japan, South Korea, and the United Kingdom.
The recall is being conducted because separation of material layers may occur, which could cause a potential risk of exposure to contaminants. The affected lot numbers are 17061767, 17061774, 17061780, 17071948, 17102915, and 17113082.
Healthcare facilities and consumers should stop using the affected products and contact Stryker for further instructions.
The recalled product
- Product
- T4 Pullover Toga, Large; Catalog Number: 0400-760-000 Sterile personal protection garment
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 34,570
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 (6)
- Lot numbers: 17061767
- 17061774
- 17061780
- 17071948
- 17102915
- 17113082
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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