Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; 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 transfer of microor
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 25,770 units of Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away sterile protective garments distributed nationwide. According to accelerated aging tests using high heat, the product's packaging may develop a breach in the sterile barrier of the header bag and blue sterilization wrap during the second and third year of shelf life, potentially compromising the sterile protection these togas are intended to provide.
The recall affects specific lot codes including 1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 1109786, 1006141, 1012303, 1102110, 1104324, and 1108664. Stryker is conducting additional testing to assess the issue further. The source record does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Based on an accelerated aging test for this product packaging, there is an indicator of 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. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr
Reason for recall: Based on an accelerated aging test for this product packaging, there is an indicator of 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. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr Distribution: USA Nationwide Distribution Quantity: 25,770 units (2,577 boxes) Lot/code info: 1006130, 1101034, 1006134, 1102133, 1007151, 1103208, 1007170, 1104297, 1009205, 1105360, 1010228, 1106476, 1010260, 1107569, 1011296, 1108676, 1012336, 11097861006141, 1012303, 1102110, 1104324, and 1108664.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.