Stryker T4 Pullover Toga Recalled for Potential Material Separation
Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 and involves a risk-of-harm product (sterile garment) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 34,570 units of T4 Pullover Toga sterile personal protection garments. The recall involves the S/M size with Catalog Number 0400-710-000. These products were distributed nationwide in the US as well as in Ireland, Japan, South Korea, and the UK.
The recall is being conducted because separation of material layers may occur. This defect creates a potential risk of exposure to contaminants. The agency has classified this as a Class II recall.
Healthcare facilities and consumers should stop using these garments and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Category
- Medical Device — Surgical Gowns
- 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 (1)
- 17071877
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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