Stryker Instruments 0400-850-100 T5 zipper Toga with recall: Sterility Concern
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect…
Why was Stryker Instruments 0400-850-100 T5 zipper Toga with 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?
1006124, 1007164, 1010236, 1011296, 1103168, 1105341, and 1108634.
- Product
- Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 6,990 units ( 699 boxes)
- Distribution
- USA Nationwide Distribution
- Recall date
- June 12, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)