FDA Device recall Z-1489-2013
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO by Stryker Instruments Div, citing 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 st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1489-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-23 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) 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, and the transfer of microorganismsand particulate material.
Reason
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
Identifiers
| code_info | 1006134, 1101020, 1106424 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1489-2013%22
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