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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

Product Description 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 microorganismsand particulate material.
Recall Number Z-1499-2013
Classification Class II
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.
Product Distributed Qty 25,770 units (2,577 boxes)
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 product packaging while initiating this recall to reduce risk of patient harm related to the remote possibility of patient infection, if a breach in packaging were present.

Event Detail

Event Id 65321
Product Type Devices
Status Ongoing
Recalling Firm Stryker Instruments Div. of Stryker Corporation
City Portage
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-23
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationwide Distribution