Stryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating 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 potential breach in the sterile barrier of a medical device, which poses a risk of harm (infection) even though no injuries have been reported yet, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling 1,980 units (198 boxes) of the T5 Pullover Toga w/Peel Away, Sterile, EO. The product is a single-use protection system intended to protect patients, healthcare personnel, and operating room personnel against contamination, exposure to infectious bodily fluids, and the transfer of microorganisms and particulate material.
The recall was initiated based on accelerated aging tests for the product packaging. These tests, which used high heat to accelerate the aging process, 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 affected products were distributed nationwide in the USA. The specific lot codes associated with this recall are 1007157 and 1103202. Healthcare facilities and consumers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description.
The recalled product
- Product
- Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, 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,
- 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 (2)
- 1007157
- 1103202
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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