Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, 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 microorganismsand particulate material.
Enforcement
- Recall Number
- Z-1498-2013
- Event ID
- 65321
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Instruments Div. of Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 12, 2013
- Initiation Date
- May 23, 2013
- Classification Date
- June 6, 2013
- Termination Date
- April 14, 2014
- Address
- 4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States
Description
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, 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 microorganismsand particulate material.
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
1005098, 1010228, 1012337, 1105367
USA Nationwide Distribution
3,980 units ( 398 boxes)