Stryker Instruments0400-720-000 T4 Pullover Toga recall: Sterility Concern
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the…
Why was Stryker Instruments0400-720-000 T4 Pullover Toga recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1005105, 1010244, 1101004, 1104289, 1107568, 1005119, 1010261, 1101030, 1104324, 1108625, 1006129, 1011276, 1101047, 1105390, 1108672, 1006140, 1011296, 1102073, 1105355, 1109730, 1007151, 1012314, 1102127, 1106431, 1109782, 1007163, 1012337, 1102131, 1106467, 1109858, 1009213, 1012346, 1104253, 1107515.
- Product
- Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 48,040 units, ( 4804 boxes)
- Distribution
- USA Nationwide Distribution
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)